Safety Recalls

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15,271 recalls across FDA food, drug, and medical device recalls, CPSC consumer products, and NHTSA vehicles.

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Showing 5,901–5,950 of 15,271

Medical Device Recall · June 25, 2025
Beckman Coulter, Inc.
DxI 600 Access Immunoassay Analyzer W/Spot B, Part Number A71460
Beckman Coulter has identified that the UniCel DxI 600/800 systems with linear slide PnP gantries running software versions 5.7 and up faced incorrect PnP X-motor current settings where the PnP X-motor current incorrectly resets to 1.5A (instead of the required 2.0A) because the software overwrites the factory setting during installs or upgrades. This anomaly causes increased PnP motion errors which could lead to delays in reporting patient sample results if unnoticed.
Class II
Food Recall · June 25, 2025
HARD EIGHT NUTRITION LLC
Brand name: BulkSupplements.com Generic name: Inositol. Dosage: 1 gram. Form: Powder. Route of administration: Oral. Packaging is flexible plastic. Net Wt.: 8.8 oz (250 grams), 1.1 lbs (500 grams),
Finished product possibly contaminated with pathogenic Staphylococcus aureus.
Class II
Medical Device Recall · June 25, 2025
Boston Scientific Corporation
FARAWAVE 1.0 Pulsed Field Ablation Catheter, Product ID M004PF41M401
The potentially impacted units were manufactured using specific equipment that may have caused cracks in the electrode bands on the catheter's distal end.
Class II
Medical Device Recall · June 25, 2025
Beckman Coulter, Inc.
DxI 600 Access Immunoassay Analyzer W/Dual Gantry, Part Number A71461
Beckman Coulter has identified that the UniCel DxI 600/800 systems with linear slide PnP gantries running software versions 5.7 and up faced incorrect PnP X-motor current settings where the PnP X-motor current incorrectly resets to 1.5A (instead of the required 2.0A) because the software overwrites the factory setting during installs or upgrades. This anomaly causes increased PnP motion errors which could lead to delays in reporting patient sample results if unnoticed.
Class II
Medical Device Recall · June 25, 2025
Preat Corp
NobelBiocare Tri-Lobe-compatible WP X 6.0mm Engaging Titanium Base, REF: 9000662
Engaging titanium base was manufactured 180 degrees around the post from where it should be located in relation to the connection geometry; if the flat is on the wrong side of the post, the crown will not fit onto the abutment in the correct orientation, resulting in restoration delay.
Class II
Food Recall · June 24, 2025
Enjoy Nutrition, LLC; dba Weyland Brain Nutrition
Lithium Orotate, 20MG, Distributed by Enjoy Nutrition, LLC. UPC#: none
Under potency / misbranding: product fails to meet labeled lithium orotate potency. (Downstream recall) from supplier of ingredient.
Class III
Drug Recall · June 24, 2025
Granules Pharmaceuticals Inc.
Metoprolol Succinate Extended-Release Tablets, USP, 25 mg, Packaged in a) 100-count bottle, NDC 70010-780-01; b) 500-count bottle, NDC 70010-780-05; Rx only, Manufactured by: Granules India Limited, H
Failed Dissolution Specifications: Product failed to meet dissolution acceptance criteria in the stability studies at the 6th month (25¿C/60% RH) long-term.
Class II
Food Recall · June 24, 2025
Enjoy Nutrition, LLC; dba Weyland Brain Nutrition
Lithium Orotate, 1MG, Distributed by Enjoy Nutrition, LLC. UPC#: 717340952714
Under potency / misbranding: product fails to meet labeled lithium orotate potency. (Downstream recall) from supplier of ingredient.
Class III
Food Recall · June 24, 2025
Enjoy Nutrition, LLC; dba Weyland Brain Nutrition
Lithium Orotate, 5MG, Distributed by Enjoy Nutrition, LLC. UPC#: 702730893968, 702730894064
Under potency / misbranding: product fails to meet labeled lithium orotate potency. (Downstream recall) from supplier of ingredient.
Class III
Medical Device Recall · June 24, 2025
Fresenius Kabi USA, LLC
LVP Blood Products Administration Set Dual-Inlet, Low-Sorbing, Y-Site, Mesh Filter (Qty 20). Product Code: SET-0014-20.
Potential for external cassette leaks
Class II
Food Recall · June 24, 2025
Moon N Sea GA LLC
Fresh Scottish Salmon Fillet, Net WT (variable weight) 50 lb brown corrugated carboard box (up to 6 fillets per box). Boxes contain ice for temperature control. Keep Refrigerated.
RTE fish (sushi-salmon, tuna) processed under insanitary conditions. The firm was notified by the Georgia Department of Agriculture that the products were manufactured under unsanitary conditions.
Class II
Medical Device Recall · June 24, 2025
Orthofix U.S. LLC
PILLAR SA Ti, STERILE, 37mm (W) x 28mm (D) x 18mm (H), 20-degrees, REF: 82-3713SP
A 37 mm implant width intervertebral body fusion device has a labeling discrepancy with incorrect width of 33 mm stated on the outer label side flap and inner label side flap information box. The 37 mm width on the front labels is correct.
Class II
Food Recall · June 24, 2025
Moon N Sea GA LLC
Fresh Chilean Salmon Fillet, Net WT (variable weight) 50 lb brown corrugated carboard box (up to 6 fillets per box). Boxes contain ice for temperature control. Keep Refrigerated.
RTE fish (sushi-salmon, tuna) processed under insanitary conditions. The firm was notified by the Georgia Department of Agriculture that the products were manufactured under unsanitary conditions.
Class II
Medical Device Recall · June 24, 2025
Preat Corp
Preat, Astra EV-compatible 4.2mm Digital Analog REF: 9006603 (single) and 9006603-10(10 pack), Rx Only
Due to manufacturing error, digital analog rotational feature is 180 degrees off.
Class II
Medical Device Recall · June 24, 2025
Fresenius Kabi USA, LLC
LVP Primary Administration Set, Single Outlet Low Sorbing (Qty 25). Product Code: SET-0021-25.
Potential for external cassette leaks
Class II
Food Recall · June 24, 2025
GMP Laboratories of America Inc
Lithium Orotate 2.5; 60 vegetarian capsules, Dietary Supplement; Distributed by Mecene LLC. 447 Sutter St., Suite 405, San Fransisco, CA 94108 2.5 mg UPC#: X002T4OPLL 10 mg UPC#: X0031AXVE9
Downstream recall of a dietary supplement ingredient that was manufactured out of specifications.
Class III
Food Recall · June 24, 2025
Moon N Sea GA LLC
Blue Fin Tuna, Net WT (variable weight) 50 lb brown corrugated carboard box. Boxes contain ice for temperature control. Keep Refrigerated.
RTE fish (sushi-salmon, tuna) processed under insanitary conditions. The firm was notified by the Georgia Department of Agriculture that the products were manufactured under unsanitary conditions.
Class II
Food Recall · June 24, 2025
Enjoy Nutrition, LLC; dba Weyland Brain Nutrition
Lithium Orotate, 10MG, Distributed by Enjoy Nutrition, LLC. UPC#: 702730894033, 702730894057
Under potency / misbranding: product fails to meet labeled lithium orotate potency. (Downstream recall) from supplier of ingredient.
Class III
Food Recall · June 24, 2025
Moon N Sea GA LLC
Yellow Fin Tuna, Net WT (variable weight) 50 lb brown corrugated carboard box. Boxes contain ice for temperature control. Keep Refrigerated.
RTE fish (sushi-salmon, tuna) processed under insanitary conditions. The firm was notified by the Georgia Department of Agriculture that the products were manufactured under unsanitary conditions.
Class II
Food Recall · June 24, 2025
Aceto US, L.L.C
a.) Actylis brand Lithium Orotate 4% packaged in HDPE Liner in a 25kg carton b.) Actylis brand Lithium Orotate 9% packaged in HDPE Liner in a 25kg carton
4% Lithium Orotate product may only contain 3% and 9% Lithium Orotate product may contain 4.45%
Class III
Medical Device Recall · June 24, 2025
Fresenius Kabi USA, LLC
LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site (Qty 25). Product Code: SET-0032-25.
Potential for external cassette leaks
Class II
Food Recall · June 24, 2025
Enjoy Nutrition, LLC; dba Weyland Brain Nutrition
Lithium Orotate, 2.5MG, Distributed by Enjoy Nutrition, LLC. UPC#: 719318414002; 709750005289
Under potency / misbranding: product fails to meet labeled lithium orotate potency. (Downstream recall) from supplier of ingredient.
Class III
Food Recall · June 24, 2025
GMP Laboratories of America Inc
Lithium Orotate, Weyland Brain Nutrition ; 60 vegetarian capsules, Dietary Supplement; Distributed by Enjoy Nutirtion, LLC. San Francisco, CA 94108, (415) 894-0537 2.5 mg UPC#: X001SBI13J 5 mg UPC#:
Downstream recall of a dietary supplement ingredient that was manufactured out of specification.
Class III
Medical Device Recall · June 24, 2025
Fresenius Kabi USA, LLC
LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty 25). Product Code: SET-0013-25.
Potential for external cassette leaks
Class II
Food Recall · June 23, 2025
NIRWANA FOODS LLC
Nirwana Foods, Golden Raisin, 28 oz (794g), Net Wt. 1.75 LBS, Clear Bags, 20 bags Per Case, keep at room Temperature
Undeclared Sulfites in product
Class II
Medical Device Recall · June 23, 2025
Thoratec LLC
Brand Name: HeartMate Product Name: Mobile Power Unit Model/Catalog Number: 107754 Software Version: N/A Product Description: The HeartMate 3" Left Ventricular Assist System (LVAS) is a set of equ
Due to misaligned V-Lock feature on the Mobile Power Unit power cords, which prevents the locking mechanism from properly engaging with the Mobile Power Unit and may cause unintended disconnect.
Class I
Medical Device Recall · June 23, 2025
Covidien
Covidien Nellcor Bedside SpO2 Patient Monitoring System: REF: PM100N, 10005941, DLPM100N, DL10005941, DSPM100N, 10005941-SG, DS10005941, 10005941J, 10005941JP, 10005941JPN
Bedside SpO2 Patient Monitoring System alarms not heard/recognized, resulting in: treatment delay, lack of low oxygen saturation response, respiratory failure, arrhythmia. Highlighting operator's manual: 1)For patient Safety don't silence/decrease alarm volume, 2)Sensor off alarm (no perfusion detected) is low priority alarm, 3)Set monitors to Homecare Mode outside of hospital/professional setting
Class II
Medical Device Recall · June 23, 2025
Becton Dickinson & Co.
BD COR System Software. Model Number: 444829.
Potential for functionality issue that supports the Over labeling feature and could lead to possible false negative results.
Class II
Medical Device Recall · June 23, 2025
Steris Corporation
Dual Flat Panel Monitor (DFPM) accessories for HarmonyAIR E-Series Surgical Lighting Systems
The DFPM yoke assembly ("yoke assembly") may detach from the spring arm. Should the yoke assembly detach from the spring arm, the yoke assembly would not be expected to fully detach but rather hang from the wiring within the yoke assembly.
Class II
Medical Device Recall · June 23, 2025
Abiomed, Inc.
Automated Impella Controller (AIC), used in left heart support blood pump, including the following: 1. Impella Controller, Packaged, AU; Product Code: 0042-0000-AU. 2. Impella Controller, Pack
A potential issue with the Automated Impella Controller (AIC) not detecting an Impella pump when it is connected
Class I
Food Recall · June 23, 2025
Henry Ford Milk Bank- Jackson
Pasteurized Donor Human Milk , 4oz plastic bottle
Foreign material (plastic particulate from outer closure) between immediate closure (foil seal) and outer closure (plastic cap)
Class III
Medical Device Recall · June 23, 2025
Steris Corporation
Dual Flat Panel Monitor (DFPM) accessories for HarmonyAIR A-Series Surgical Lighting Systems
The DFPM yoke assembly ("yoke assembly") may detach from the spring arm. Should the yoke assembly detach from the spring arm, the yoke assembly would not be expected to fully detach but rather hang from the wiring within the yoke assembly.
Class II
Medical Device Recall · June 23, 2025
Thoratec LLC
Brand Name: HeartMate Product Name: Mobile Power Unit, AC Power Cord Model/Catalog Number: 107760 Software Version: N/A Product Description: The HeartMate 3" Left Ventricular Assist System (LVAS)
Due to misaligned V-Lock feature on the Mobile Power Unit power cords, which prevents the locking mechanism from properly engaging with the Mobile Power Unit and may cause unintended disconnect.
Class I
Medical Device Recall · June 20, 2025
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Infinia, Infinia Hawkeye, Infinia II, Infinia II Hawkeye 4 Nuclear Medicine system
Unintended radial detector motion may occur during patient setup or during patient scan if system does not have correct version of gantry software installed. Unintended detector motion may result in life-threatening injury.
Class II
Drug Recall · June 20, 2025
Lupin Pharmaceuticals Inc.
Lisinopril and Hydrochlorothiazide Tablets USP 20mg/12.5mg, 100-count bottles, Rx only, Mfg for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202, Manufactured by: Lupin Limited Nagpur-441 108, INDIA,
Product Mix Up: This product is being recalled because of a complaint received that a sealed bottle of lisinopril and hydrochlorothiazide tablets 20mg/12.5 mg had a foreign tablet identified as atazanavir and ritonavir tablet 300mg/100mg.
Class II
Medical Device Recall · June 20, 2025
GE Medical Systems, LLC
GE SIGNA Architect, Nuclear Magnetic Resonance Imaging System
GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA Premier, SIGNA UHP, Discovery MR750 3.0T, Discovery MR750w 3.0T, SIGNA Hero, SIGNA PET/MR, SIGNA Artist Evo, SIGNA Voyager AIR (China Only), SIGNA Architect AIR (China Only), SIGNA Premier XT (China Only), SIGNA Premier Elite (China Only), SIGNA Premier MAX (China Only), SIGNA Hero XT (China Only), SIGNA Hero Elite (China Only), SIGNA Hero MAX (China Only), SIGNA PET/MR AIR (China Only), SIGNA PET/MR AIR Plus (China Only), the planned maintenance steps to check the functionality of the caster locks on the MR patient table may not have been performed.
Class II
Medical Device Recall · June 20, 2025
GE Medical Systems, LLC
GE Discovery MR750w 3.0T, Nuclear Magnetic Resonance Imaging System
GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA Premier, SIGNA UHP, Discovery MR750 3.0T, Discovery MR750w 3.0T, SIGNA Hero, SIGNA PET/MR, SIGNA Artist Evo, SIGNA Voyager AIR (China Only), SIGNA Architect AIR (China Only), SIGNA Premier XT (China Only), SIGNA Premier Elite (China Only), SIGNA Premier MAX (China Only), SIGNA Hero XT (China Only), SIGNA Hero Elite (China Only), SIGNA Hero MAX (China Only), SIGNA PET/MR AIR (China Only), SIGNA PET/MR AIR Plus (China Only), the planned maintenance steps to check the functionality of the caster locks on the MR patient table may not have been performed.
Class II
Medical Device Recall · June 20, 2025
GE Medical Systems, LLC
GE SIGNA Premier MAX (China Only), Nuclear Magnetic Resonance Imaging System
GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA Premier, SIGNA UHP, Discovery MR750 3.0T, Discovery MR750w 3.0T, SIGNA Hero, SIGNA PET/MR, SIGNA Artist Evo, SIGNA Voyager AIR (China Only), SIGNA Architect AIR (China Only), SIGNA Premier XT (China Only), SIGNA Premier Elite (China Only), SIGNA Premier MAX (China Only), SIGNA Hero XT (China Only), SIGNA Hero Elite (China Only), SIGNA Hero MAX (China Only), SIGNA PET/MR AIR (China Only), SIGNA PET/MR AIR Plus (China Only), the planned maintenance steps to check the functionality of the caster locks on the MR patient table may not have been performed.
Class II
Medical Device Recall · June 20, 2025
GE Medical Systems, LLC
GE Optima MR450w 1.5T, Nuclear Magnetic Resonance Imaging System
GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA Premier, SIGNA UHP, Discovery MR750 3.0T, Discovery MR750w 3.0T, SIGNA Hero, SIGNA PET/MR, SIGNA Artist Evo, SIGNA Voyager AIR (China Only), SIGNA Architect AIR (China Only), SIGNA Premier XT (China Only), SIGNA Premier Elite (China Only), SIGNA Premier MAX (China Only), SIGNA Hero XT (China Only), SIGNA Hero Elite (China Only), SIGNA Hero MAX (China Only), SIGNA PET/MR AIR (China Only), SIGNA PET/MR AIR Plus (China Only), the planned maintenance steps to check the functionality of the caster locks on the MR patient table may not have been performed.
Class II
Drug Recall · June 20, 2025
ACCORD HEALTHCARE, INC.
Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Ro
Subpotent Drug: Assay below the approved specification
Class II
Medical Device Recall · June 20, 2025
GE Medical Systems, LLC
GE SIGNA Hero XT (China Only), Nuclear Magnetic Resonance Imaging System
GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA Premier, SIGNA UHP, Discovery MR750 3.0T, Discovery MR750w 3.0T, SIGNA Hero, SIGNA PET/MR, SIGNA Artist Evo, SIGNA Voyager AIR (China Only), SIGNA Architect AIR (China Only), SIGNA Premier XT (China Only), SIGNA Premier Elite (China Only), SIGNA Premier MAX (China Only), SIGNA Hero XT (China Only), SIGNA Hero Elite (China Only), SIGNA Hero MAX (China Only), SIGNA PET/MR AIR (China Only), SIGNA PET/MR AIR Plus (China Only), the planned maintenance steps to check the functionality of the caster locks on the MR patient table may not have been performed.
Class II
Medical Device Recall · June 20, 2025
GE Medical Systems, LLC
GE SIGNA Voyager AIR (China Only), Nuclear Magnetic Resonance Imaging System
GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA Premier, SIGNA UHP, Discovery MR750 3.0T, Discovery MR750w 3.0T, SIGNA Hero, SIGNA PET/MR, SIGNA Artist Evo, SIGNA Voyager AIR (China Only), SIGNA Architect AIR (China Only), SIGNA Premier XT (China Only), SIGNA Premier Elite (China Only), SIGNA Premier MAX (China Only), SIGNA Hero XT (China Only), SIGNA Hero Elite (China Only), SIGNA Hero MAX (China Only), SIGNA PET/MR AIR (China Only), SIGNA PET/MR AIR Plus (China Only), the planned maintenance steps to check the functionality of the caster locks on the MR patient table may not have been performed.
Class II
Medical Device Recall · June 20, 2025
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Varicam, Millennium VG, Millennium VG Hawkeye, Discovery VH Nuclear Medicine System
Unintended radial detector motion may occur during patient setup or during patient scan if system does not have correct version of gantry software installed. Unintended detector motion may result in life-threatening injury.
Class II
Medical Device Recall · June 20, 2025
GE Medical Systems, LLC
GE SIGNA PET/MR AIR Plus (China Only), Nuclear Magnetic Resonance Imaging System
GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA Premier, SIGNA UHP, Discovery MR750 3.0T, Discovery MR750w 3.0T, SIGNA Hero, SIGNA PET/MR, SIGNA Artist Evo, SIGNA Voyager AIR (China Only), SIGNA Architect AIR (China Only), SIGNA Premier XT (China Only), SIGNA Premier Elite (China Only), SIGNA Premier MAX (China Only), SIGNA Hero XT (China Only), SIGNA Hero Elite (China Only), SIGNA Hero MAX (China Only), SIGNA PET/MR AIR (China Only), SIGNA PET/MR AIR Plus (China Only), the planned maintenance steps to check the functionality of the caster locks on the MR patient table may not have been performed.
Class II
Drug Recall · June 20, 2025
ACCORD HEALTHCARE, INC.
Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 90-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road,
Subpotent Drug: Assay below the approved specification
Class II
Medical Device Recall · June 20, 2025
GE Medical Systems, LLC
GE SIGNA UHP, Nuclear Magnetic Resonance Imaging System
GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA Premier, SIGNA UHP, Discovery MR750 3.0T, Discovery MR750w 3.0T, SIGNA Hero, SIGNA PET/MR, SIGNA Artist Evo, SIGNA Voyager AIR (China Only), SIGNA Architect AIR (China Only), SIGNA Premier XT (China Only), SIGNA Premier Elite (China Only), SIGNA Premier MAX (China Only), SIGNA Hero XT (China Only), SIGNA Hero Elite (China Only), SIGNA Hero MAX (China Only), SIGNA PET/MR AIR (China Only), SIGNA PET/MR AIR Plus (China Only), the planned maintenance steps to check the functionality of the caster locks on the MR patient table may not have been performed.
Class II
Medical Device Recall · June 20, 2025
Intersurgical Inc
One-piece Guedel airway, size 3, ISO 9.0, yellow. Model Number: 1113090.
Potential contamination with small burrs, which if detach could be inhaled and result in potential complications such as airway obstruction, tissue irritation, inflammation and infection.
Class II
Medical Device Recall · June 20, 2025
GE Medical Systems, LLC
GE SIGNA Artist Evo, Nuclear Magnetic Resonance Imaging System
GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA Premier, SIGNA UHP, Discovery MR750 3.0T, Discovery MR750w 3.0T, SIGNA Hero, SIGNA PET/MR, SIGNA Artist Evo, SIGNA Voyager AIR (China Only), SIGNA Architect AIR (China Only), SIGNA Premier XT (China Only), SIGNA Premier Elite (China Only), SIGNA Premier MAX (China Only), SIGNA Hero XT (China Only), SIGNA Hero Elite (China Only), SIGNA Hero MAX (China Only), SIGNA PET/MR AIR (China Only), SIGNA PET/MR AIR Plus (China Only), the planned maintenance steps to check the functionality of the caster locks on the MR patient table may not have been performed.
Class II
Food Recall · June 20, 2025
CinFranky LLC dba New Mexico Pinon Coffee
New Mexico Pinon Coffee. Dark Pinon Single Serve 10ct. Product Number:F03308 UPC:812361033081. Single Serve (Keurig) Cups, filled with ground coffee flavored with natural flavorings.
Clear coat seal on the lid of the single serve cups did not get applied consistently to all cups in the production run. This resulted in the food safe ink printing on some cups to run when exposed to high temperature, high-pressure water used in a K-cup machine.
Class III
Medical Device Recall · June 20, 2025
GE Medical Systems, LLC
GE Signa Artist, Nuclear Magnetic Resonance Imaging System
GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA Premier, SIGNA UHP, Discovery MR750 3.0T, Discovery MR750w 3.0T, SIGNA Hero, SIGNA PET/MR, SIGNA Artist Evo, SIGNA Voyager AIR (China Only), SIGNA Architect AIR (China Only), SIGNA Premier XT (China Only), SIGNA Premier Elite (China Only), SIGNA Premier MAX (China Only), SIGNA Hero XT (China Only), SIGNA Hero Elite (China Only), SIGNA Hero MAX (China Only), SIGNA PET/MR AIR (China Only), SIGNA PET/MR AIR Plus (China Only), the planned maintenance steps to check the functionality of the caster locks on the MR patient table may not have been performed.
Class II