Medical Device Recalls
RSS ↗7,959 medical device recalls from federal enforcement feeds.
Showing 4,001–4,050 of 7,959
- Class II
Medical Device Recall · January 16, 2025
Plato 17 Microcatheter REF PL17-160-090 To assist in delivery of therapeutic devices and embolization materials and infusion of diagnostic agents to the neuro and peripheral vasculature during inteDue to manufacturing non-conformance that resulted in channels in the seal on the packaging pouch. As a result, this could potential create a breach in the sterile barrier.
- Class II
Medical Device Recall · January 16, 2025
Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 5.0.2.35 and 5.0.3.17 Software Version: RayStation 5 Service Pack 2 and 3Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, Robust evaluation and Compute perturbed dose for proton and light ion treatment plans when a HU-to-mass density CT calibration curve used in RayStation version 4.5 to 2024B including some service packs.
- Class II
Medical Device Recall · January 16, 2025
Brand Name: RayStation -Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 9.1.0.933, 9.2.0.483, 10.0.0.1154, 10.0.1.52 and 10.0.2.10 Software Version: RayStation 9B,Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, Robust evaluation and Compute perturbed dose for proton and light ion treatment plans when a HU-to-mass density CT calibration curve used in RayStation version 4.5 to 2024B including some service packs.
- Class II
Medical Device Recall · January 16, 2025
Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 6.0.0.24 Software Version: RayStation 6Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, Robust evaluation and Compute perturbed dose for proton and light ion treatment plans when a HU-to-mass density CT calibration curve used in RayStation version 4.5 to 2024B including some service packs.
- Class II
Medical Device Recall · January 16, 2025
Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 12.0.0.932, 12.1.0.1221, 12.0.3.68, 12.0.4.12 and 12.3.0.119 Software Version: RayStation 11BInconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, Robust evaluation and Compute perturbed dose for proton and light ion treatment plans when a HU-to-mass density CT calibration curve used in RayStation version 4.5 to 2024B including some service packs.
- Class II
Medical Device Recall · January 16, 2025
Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 10.1.0.613 and 10.1.1.54 Software Version: RayStation 10B and 10B Service Pack 1Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, Robust evaluation and Compute perturbed dose for proton and light ion treatment plans when a HU-to-mass density CT calibration curve used in RayStation version 4.5 to 2024B including some service packs.
- Class II
Medical Device Recall · January 16, 2025
Brand Name: RayStation Intended as a Radiation Therapy Treatment Planning System. Model/Catalog Number: 7.0.0.19, 8.0.0.61, 8.0.1.10 Software Version: RayStation 7, 8A and 8A Service Pack 1Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, Robust evaluation and Compute perturbed dose for proton and light ion treatment plans when a HU-to-mass density CT calibration curve used in RayStation version 4.5 to 2024B including some service packs.
- Class II
Medical Device Recall · January 16, 2025
Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 6.1.1.2, 6.2.0.7, 6.3.0.6 Software Version: RayStation 6 Service Pack 1, 2 and 3Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, Robust evaluation and Compute perturbed dose for proton and light ion treatment plans when a HU-to-mass density CT calibration curve used in RayStation version 4.5 to 2024B including some service packs.
- Class I
Medical Device Recall · January 15, 2025
Olympus Corporation of the Americas
Olympus Single Use Guide Sheath Kits with the following product descriptions and model numbers: 1. Single Use Guide Sheath Kit K-201 2.0MM Channel Set: Guide Sheath, Biopsy Forceps, Cytology Brush;Potential for the radiopaque tip of the guide sheath component to disassociate and fall off into the patient.
- Class II
Medical Device Recall · January 15, 2025
IntelliBridge EC10 Module. Model Number: 865115Potential failure to alarm for "No Device Data" INOP. The device to alarm after a Hamilton ventilator is disconnected from the EC10 Module or IntelliBridge I/O board.
- Class II
Medical Device Recall · January 15, 2025
ASP BIOTRACE Auto Read 60 Steam BI Process Challenge Device, REF 73135.Error in the IFU lists an incorrect incubation time on one occasion of 20 minutes rather than the correct incubation time of 60 minutes.
- Class II
Medical Device Recall · January 15, 2025
Brand Name: Sertera Biopsy Device Product Name: Sertera Biopsy Device Model/Catalog Number: Sertera-14 Software Version: N/A Product Description: Instrument, Biopsy Component: N/ADevices presented a condition in which the inner needle separated from the hub and produced a longer throw of the inner needle or dislodgement.
- Class II
Medical Device Recall · January 15, 2025
IntelliVue Patient Monitor MX550. Model Number: 866066Potential failure to alarm for "No Device Data" INOP. The device to alarm after a Hamilton ventilator is disconnected from the EC10 Module or IntelliBridge I/O board.
- Class II
Medical Device Recall · January 15, 2025
IntelliVue Patient Monitor MX400. Model Number: 866060Potential failure to alarm for "No Device Data" INOP. The device to alarm after a Hamilton ventilator is disconnected from the EC10 Module or IntelliBridge I/O board.
- Class II
Medical Device Recall · January 15, 2025
IntelliVue Patient Monitor MX450. Model Number: 866062Potential failure to alarm for "No Device Data" INOP. The device to alarm after a Hamilton ventilator is disconnected from the EC10 Module or IntelliBridge I/O board.
- Class II
Medical Device Recall · January 15, 2025
DeRoyal AMG Suction Connector Tubing REF: 71-2083, 71-C506, 71-C510, 71-C512, 71-C520, Tubing is intended for fluid movementThe tubing may not ensure that the yankauer stays intact, and secure to the tubing / yankauer connection for a tight seal. This could result in inadequate suction and cause delay in patient care.
- Class II
Medical Device Recall · January 15, 2025
MOSAIQ Oncology Information SystemImage offsets calculated by oncology Information System software may be incorrect for Linear Accelerator (LINACs) not characterized at IEC61217 scale.
- Class II
Medical Device Recall · January 15, 2025
IntelliVue Patient Monitor MX500. Model Number: 866064Potential failure to alarm for "No Device Data" INOP. The device to alarm after a Hamilton ventilator is disconnected from the EC10 Module or IntelliBridge I/O board.
- Class I
Medical Device Recall · January 15, 2025
Vaporizer Sevoflurane, Quik-Fil. Model Number: 6682285. Device is a component of Flow-i C20, Flow-i C30, Flow-i C40, Flow-c, Flow-e. For use during anesthesia.Sevoflurane used with the vaporizer may degrade to hydrogen fluoride, which could present a risk to patients or health care providers through inhalation and/or skin exposure. Potential harms include irritation of respiratory tract, which in worst case may lead to lung edema and/or severe hypocalcemia, blistering, superficial ulceration, and/or hypomagnesemia.
- Class II
Medical Device Recall · January 14, 2025
Infinity Central Station. Model Number: MS26800 The Infinity CentralStation (ICS) is intended for centralized monitoring of adult, pediatric and neonatal patient data within the hospital or clinicaEdifier speakers (shipped in or after April 2023) may not annunciate when configured in analog mode which can lead to delayed treatment to the patient.
- Class I
Medical Device Recall · January 13, 2025
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD20/20; Catalog numbers: 722038Possibility 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 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.
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 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.
Allura Xper FD20/10; Catalog numbers: 722029Possibility 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.
AlluraXper FD20 Biplane OR Table System Code: (1) 722020 (2) 722025Potential 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.
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 I
Medical Device Recall · January 13, 2025
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD20 OR Table; Catalog numbers: (1) 722023, (2) 722035.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 FD10/10; Catalog numbers: (1) 722005, (2) 722011, (3) 722027.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 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.
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 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 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.
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 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 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 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 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.
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 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 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.
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 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 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 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.
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 II
Medical Device Recall · January 13, 2025
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
AlluraXper FD20 Biplane System Code: (1) 722008 (2) 722013Potential 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 FD20/15; Catalog numbers: 722058Possibility 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 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