Medical Device Recalls
RSS ↗8,689 medical device recalls from federal enforcement feeds.
Showing 4,751–4,800 of 8,689
- Class II
Medical Device Recall · January 13, 2025
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Azurion 7 M20 System code: (1) 722224 (2) 722079 (3) 722234 (4) 722282 System Code: (1) 722078 (2) 722223 (3) 722233Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. During manual repositioning of the patient tabletop, a finger can get entrapped between the longitudinal guiding rails and the tabletop. This may result in an injury of the finger, applicable for operators and service personnel
- Class II
Medical Device Recall · January 13, 2025
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Azurion 3 M12 System Code: (1) 722063 (2) 722221Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. During manual repositioning of the patient tabletop, a finger can get entrapped between the longitudinal guiding rails and the tabletop. This may result in an injury of the finger, applicable for operators and service personnel
- Class I
Medical Device Recall · January 13, 2025
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Azurion 7 B12; Catalog numbers: (1) 722067, (2) 722225, (3) 722235 (OUS ONLY).Possibility of the patient falling from the table related to the mattress used on the patient table.
- Class II
Medical Device Recall · January 13, 2025
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
AlluraXper FD10/10 System Code: (1) 722005 (2) 722011 (3) 722027Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. During manual repositioning of the patient tabletop, a finger can get entrapped between the longitudinal guiding rails and the tabletop. This may result in an injury of the finger, applicable for operators and service personnel
- Class II
Medical Device Recall · January 13, 2025
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD10C System Code: (1) 722001Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. During manual repositioning of the patient tabletop, a finger can get entrapped between the longitudinal guiding rails and the tabletop. This may result in an injury of the finger, applicable for operators and service personnel
- Class I
Medical Device Recall · January 13, 2025
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Azurion 5 M20; Catalog numbers: (1) 722228, (2) 722232 (OUS ONLY), (3) 722281 (OUS ONLY).Possibility of the patient falling from the table related to the mattress used on the patient table.
- Class I
Medical Device Recall · January 13, 2025
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Cardio Vascular-Allura Centron; Catalog number: 722400 (OUS ONLY).Possibility of the patient falling from the table related to the mattress used on the patient table.
- Class II
Medical Device Recall · January 13, 2025
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
AlluraXper FD20 OR Table System Code: (1) 722023 (2) 722035Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. During manual repositioning of the patient tabletop, a finger can get entrapped between the longitudinal guiding rails and the tabletop. This may result in an injury of the finger, applicable for operators and service personnel
- Class I
Medical Device Recall · January 13, 2025
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Azurion 7 M12; Catalog numbers: (1) 722078, (2) 722223, (3) 722233 (OUS ONLY).Possibility of the patient falling from the table related to the mattress used on the patient table.
- Class I
Medical Device Recall · January 13, 2025
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD10 - Catalog numbers: (1) 722003, (2) 722010, (3) 722026,Possibility of the patient falling from the table related to the mattress used on the patient table.
- Class I
Medical Device Recall · January 13, 2025
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD10C; Catalog number: 722001Possibility of the patient falling from the table related to the mattress used on the patient table.
- Class II
Medical Device Recall · January 13, 2025
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Azurion 3 M15 System Code: (1) 722064 (2) 722222 (3) 722280Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. During manual repositioning of the patient tabletop, a finger can get entrapped between the longitudinal guiding rails and the tabletop. This may result in an injury of the finger, applicable for operators and service personnel
- Class II
Medical Device Recall · January 13, 2025
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Azurion 7 B12 System Code: (1) 722067 (2) 722225 (3) 722235Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. During manual repositioning of the patient tabletop, a finger can get entrapped between the longitudinal guiding rails and the tabletop. This may result in an injury of the finger, applicable for operators and service personnel
- Class II
Medical Device Recall · January 13, 2025
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD10 Catalog (1) 722003 (2) 722010 (3)722026Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. During manual repositioning of the patient tabletop, a finger can get entrapped between the longitudinal guiding rails and the tabletop. This may result in an injury of the finger, applicable for operators and service personnel
- Class II
Medical Device Recall · January 13, 2025
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Azurion 5 M20 System Code: (1) 722228 (2) 722232 (3) 722281Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. During manual repositioning of the patient tabletop, a finger can get entrapped between the longitudinal guiding rails and the tabletop. This may result in an injury of the finger, applicable for operators and service personnel
- Class II
Medical Device Recall · January 13, 2025
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
AlluraXper FD20 System Code: (1) 722006 (2) 722012 (3) 722028Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. During manual repositioning of the patient tabletop, a finger can get entrapped between the longitudinal guiding rails and the tabletop. This may result in an injury of the finger, applicable for operators and service personnel
- Class I
Medical Device Recall · January 13, 2025
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Azurion 3 M12; Catalog numbers: (1) 722063, (2) 722221.Possibility of the patient falling from the table related to the mattress used on the patient table.
- Class II
Medical Device Recall · January 13, 2025
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
AlluraXperFD20/15 System Code: (1) 722058Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. During manual repositioning of the patient tabletop, a finger can get entrapped between the longitudinal guiding rails and the tabletop. This may result in an injury of the finger, applicable for operators and service personnel
- Class I
Medical Device Recall · January 13, 2025
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD20 Biplane; Catalog numbers: (1) 722008, (2) 722013.Possibility of the patient falling from the table related to the mattress used on the patient table.
- Class I
Medical Device Recall · January 13, 2025
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Azurion 3 M15; Catalog numbers: (1) 722064, (2) 722222 (3) 722280(OUS ONLY).Possibility of the patient falling from the table related to the mattress used on the patient table.
- Class II
Medical Device Recall · January 13, 2025
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Azurion 7 M12 System Code: (1) 722078 (2) 722223 (3) 722233Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. During manual repositioning of the patient tabletop, a finger can get entrapped between the longitudinal guiding rails and the tabletop. This may result in an injury of the finger, applicable for operators and service personnel
- Class I
Medical Device Recall · January 13, 2025
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Azurion 7 M20; Catalog numbers: (1) 722079, (2) 722224, (3) 722234, (4) 722282 (OUS ONLY);Possibility of the patient falling from the table related to the mattress used on the patient table.
- Class II
Medical Device Recall · January 13, 2025
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura CV20 System Code: 722031Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. During manual repositioning of the patient tabletop, a finger can get entrapped between the longitudinal guiding rails and the tabletop. This may result in an injury of the finger, applicable for operators and service personnel
- Class II
Medical Device Recall · January 13, 2025
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Azurion 7 B20 System Code: (1) 722068 (2) 722226 (3) 722236Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. During manual repositioning of the patient tabletop, a finger can get entrapped between the longitudinal guiding rails and the tabletop. This may result in an injury of the finger, applicable for operators and service personnel
- Class I
Medical Device Recall · January 13, 2025
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD20; Catalog numbers: (1) 722006, (2) 722012, (3) 722028.Possibility of the patient falling from the table related to the mattress used on the patient table.
- Class II
Medical Device Recall · January 13, 2025
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
AlluraXperFD20/10 System Code: (1) 722029Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. During manual repositioning of the patient tabletop, a finger can get entrapped between the longitudinal guiding rails and the tabletop. This may result in an injury of the finger, applicable for operators and service personnel
- Class I
Medical Device Recall · January 13, 2025
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Azurion 5 M12; Catalog numbers: (1) 722227, (2) 722231 (OUS ONLY).Possibility of the patient falling from the table related to the mattress used on the patient table.
- Class I
Medical Device Recall · January 13, 2025
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD20 Biplane OR Table; Catalog numbers: (1) 722020, (2) 722025.Possibility of the patient falling from the table related to the mattress used on the patient table.
- Class II
Medical Device Recall · January 13, 2025
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Azurion 5 M12 System Code: (1) 722227 (2) 722231Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. During manual repositioning of the patient tabletop, a finger can get entrapped between the longitudinal guiding rails and the tabletop. This may result in an injury of the finger, applicable for operators and service personnel
- Class I
Medical Device Recall · January 13, 2025
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura CV20; Catalog numbers: 722031Possibility of the patient falling from the table related to the mattress used on the patient table.
- Class I
Medical Device Recall · January 13, 2025
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Azurion 7 B20; Catalog numbers: (1) 722068, (2) 722226, (3) 722236.Possibility of the patient falling from the table related to the mattress used on the patient table.
- Class II
Medical Device Recall · January 13, 2025
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD20/20 System Code: (1) 722038Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. During manual repositioning of the patient tabletop, a finger can get entrapped between the longitudinal guiding rails and the tabletop. This may result in an injury of the finger, applicable for operators and service personnel
- Class I
Medical Device Recall · January 10, 2025
Intact Vascular Tack Endovascular System, to treat vascular dissections with Tack implant(s) following angioplasty: (4F,1.5-4.5mm), 150cm, REF: 154150041; Tack, 4F Gen 1.5, 150cm CE, REF: 154150042; TUse of Tack Endovascular system, designed to treat acute dissections of inner wall or lining of an artery by tacking damaged tissue to inner luminal surface, could result in problems with deployment and stability of device in vessel after deployment, which may cause failure to resolve dissection, migration of implant, bailout stenting, reintervention, unintended removal of tack devices, and ischemia.
- Class II
Medical Device Recall · January 10, 2025
Brand Name: MediHoney¿ Gel Product Name: MediHoney¿ Wound & Burn Dressing Gel Model/Catalog Number: 31815 Software Version: N/A Product Description: MediHoney¿ Gel with Active Leptospermum Honey iPotential that the induction seal is not completely sealed to the device tube packaging.
- Class I
Medical Device Recall · January 10, 2025
Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Indicated for use in a hospital and in outpatient care environments for the controlled administration of fluids through clinically accepted rLarge Volume Pump Software, version 5.9.2 and earlier has potential for the following anomalies: 1. The pump may become nonfunctional if during an alarm condition the Pause Audio option is repeated 70 time or more. 2. If a secondary infusion is started at the exact moment a primary infusion completes and VTBI reaches 0, it will switch to primary. The primary infusion will infuse at the previously programed primary rate and continue until the infusion is stopped or the bag is empty.
- Class II
Medical Device Recall · January 10, 2025
. Nobel Biocare N1 TiUltra TCC RP 4.0x9mm . Nobel Biocare N1 TiUltra TCC RP 4.0x11mm . Nobel Biocare N1 TiUltra TCC RP 4.0x13mm Nobel Biocare N1 TiUltra TCC implants are intended for use as an enDue to manufacturing issue (unintended by-product of the injection molding process) a sharp pin that may puncture the blister packaging and breaching the sterile barrier of the finished product.
- Class II
Medical Device Recall · January 10, 2025
BECKMAN COULTER LABORATORY SYSTEMS (SUZHOU) CO., LTD.
DxC 500 AU Clinical Chemistry Analyzer, REF: C63519, and C63520 with affected software.Beckman Coulter has identified an issue which prevents the DxC 500 AU instrument from providing the correct onboard stability (Open Expiration) dates for assays that were loaded prior to a software upgrade (e.g. 1.3 to 1.4, 1.4 to 1.4.1, etc.). As a result, assays that have expired may still be used for sample processing, leading to inaccurate or erroneous patient test results. The issue only happens on assays loaded before instruments doing upgrades and does not impact new installation. It does not impact the assays loaded after upgrade.
- Class II
Medical Device Recall · January 10, 2025
BD Pyxis: MedFlex, REF: 1119-00; MedBank Tower REF: 1145-00; MedBank MedPass, REF: 139088-01 and associated BD Pyxis user/software/safety guides and quick reference guides.Automated dispensing device labeling is being updated to strengthen labeling around manual access to medications to address the risk of potential delays in retrieving contents/ accessing medications that may result from power loss or potential automated dispensing device malfunctions.
- Class II
Medical Device Recall · January 9, 2025
MEDLINE INDUSTRIES, LP - Northfield
Medline Convenience Kits for Various Procedures: 1) ADULT INTUBATION TRAY, Model Number DYNJAA254A; 2) ADULT MAIN DISP. INTUB PART A, Model Number DYNJAA262AKits contain recalled components due to reports of reduced skin barrier wear time. This refers to a shorter duration that a skin barrier can effectively adhere to and protect the skin before it needs to be replaced.
- Class II
Medical Device Recall · January 9, 2025
MEDLINE INDUSTRIES, LP - Northfield
Medline Convenience Kits for Various Procedures: 1) CLOVIS RESP/INTUB DRAWER 2, Model Number ACC010809; 2) RESP/INTUBATION DRAWER #2, Model Number ACC010813Kits contain recalled components due to reports of reduced skin barrier wear time. This refers to a shorter duration that a skin barrier can effectively adhere to and protect the skin before it needs to be replaced.
- Class II
Medical Device Recall · January 9, 2025
CircuitGuard Bacterial/Viral Filter with Elbow (Model/Catalogue number: SK200FPE / 7056)The machine side connector of the filter HME may be occluded by plastic which prevents proper airflow. The issue may lead to ventilation bag malfunction in which the user is unable to inflate/deflate properly during manual ventilation. Potential risks to health include oxygen deprivation, leading to respiratory distress and medical complications.
- Class II
Medical Device Recall · January 9, 2025
CircuitGuard ThermoFlo Filter -Combined Heat and Moisture Exchanger, Bacterial Viral Filter w O2 Port and Elbow (Model/Catalogue number: SK200CPE / 6126)The machine side connector of the filter HME may be occluded by plastic which prevents proper airflow. The issue may lead to ventilation bag malfunction in which the user is unable to inflate/deflate properly during manual ventilation. Potential risks to health include oxygen deprivation, leading to respiratory distress and medical complications.
- Class II
Medical Device Recall · January 9, 2025
A820 myPTM Software Application associated with Medtronic SynchroMed Pump and Infusion System.Product complaints were received describing the A820 myPTM app taking longer than expected for patients to interact with their implantable pump.
- Class II
Medical Device Recall · January 8, 2025
stryker Precision Thin, Catalog Number REF 2296-003-108; Micro Oscillating and Sagittal BladesPrecision Thin blade attachments have a potential to be out of measurement specifications, preventing them from securely fitting into the compatible handpiece.
- Class II
Medical Device Recall · January 8, 2025
139054-01 BD PYXIS MEDFLEX MN 1000 10HH-1FM 139055-01 BD PYXIS MEDFLEX MN 1000 12HH 139053-01 BD PYXIS MEDFLEX MN 1000 2HH-2FH-3FM 139041-01 BD PYXIS MEDFLEX MN 1000 2HH-2FM 139046-01 BD PYXIS MEDFLEXLabeling update to include a contraindication statement against the use of medicine cabinets in procedure and operating rooms.
- Class II
Medical Device Recall · January 8, 2025
stryker Precision Thin, Catalog Number REF 2296-003-155; Micro Oscillating and Sagittal BladesPrecision Thin blade attachments have a potential to be out of measurement specifications, preventing them from securely fitting into the compatible handpiece.
- Class II
Medical Device Recall · January 8, 2025
(1) Pyxis MedStation ES, Catalog No. 323; (2) Pyxis Anesthesia Station (PAS), Catalog No. 327; (3) Pyxis MedStation ES Tower, Catalog No. 352; (4) BD Pyxis CII Safe ES, Catalog No. 1116-00Software issues could potentially result in: 1) delays in accessing dispensing software application, 2) wrong therapy (dose, item, timing, etc.), or 3) unauthorized access and/or compliance related issues
- Class II
Medical Device Recall · January 8, 2025
138913-01 BD PYXIS MEDBANK MINI CR-2HH-1FH-P 169-114 BD PYXIS MEDBANK MINI CR-2HH-1FH-P 138911-01 BD PYXIS MEDBANK MINI CR-4HH-P 169-115 BD PYXIS MEDBANK MINI CR-4HH-P 139001-01 BD PYXIS MEDBANK MN 20Labeling update to include a contraindication statement against the use of medicine cabinets in procedure and operating rooms.
- Class II
Medical Device Recall · January 8, 2025
139088-01 BD PYXIS MEDBANK MEDPASS MODULE 169-151 BD PYXIS MEDBANK MINI 1FH-2HH MEDPASS 169-152 BD PYXIS MEDBANK MINI 2HH-1FM MEDPASS 169-150 BD PYXIS MEDBANK MINI 4HH MEDPASS 169-140 BD PYXIS MEDBANKLabeling update to include a contraindication statement against the use of medicine cabinets in procedure and operating rooms.
- Class II
Medical Device Recall · January 8, 2025
The MSOT Acuity Echo is a Class 4 medical laser device. The MSOT Acuity is a mobile assembly of electrically-powered components intended for imaging and analysis of soft-tissue and vasculature using cThe MSOT Acuity Echo does not include an adequate instruction for safe operation of the device. The previous version of the user manuals contained a wrong value for the Nominal Ocular Hazard Distance (NOHD).