February 26, 2025Medical DevicesFDA
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Azurion 7 B12; Catalog numbers: (1) 722067, (2) 722225, (3) 722235 (OUS ONLY).
Hazard: Possibility of the patient falling from the table related to the mattress used on the patient table.
February 26, 2025Medical DevicesFDA
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Azurion 5 M20; Catalog numbers: (1) 722228, (2) 722232 (OUS ONLY), (3) 722281 (OUS ONLY).
Hazard: Possibility of the patient falling from the table related to the mattress used on the patient table.
February 26, 2025Medical DevicesFDA
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Azurion 5 M12; Catalog numbers: (1) 722227, (2) 722231 (OUS ONLY).
Hazard: Possibility of the patient falling from the table related to the mattress used on the patient table.
February 26, 2025Medical DevicesFDA
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Azurion 3 M15; Catalog numbers: (1) 722064, (2) 722222 (3) 722280(OUS ONLY).
Hazard: Possibility of the patient falling from the table related to the mattress used on the patient table.
February 26, 2025Medical DevicesFDA
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Azurion 3 M12; Catalog numbers: (1) 722063, (2) 722221.
Hazard: Possibility of the patient falling from the table related to the mattress used on the patient table.
February 26, 2025Medical DevicesFDA
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Allura Xper FD10C; Catalog number: 722001
Hazard: Possibility of the patient falling from the table related to the mattress used on the patient table.
February 26, 2025Medical DevicesFDA
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Allura CV20; Catalog numbers: 722031
Hazard: Possibility of the patient falling from the table related to the mattress used on the patient table.
February 26, 2025Medical DevicesFDA
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Allura Xper FD20/20; Catalog numbers: 722038
Hazard: Possibility of the patient falling from the table related to the mattress used on the patient table.
February 26, 2025Medical DevicesFDA
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Allura Xper FD20/15; Catalog numbers: 722058
Hazard: Possibility of the patient falling from the table related to the mattress used on the patient table.
February 26, 2025Medical DevicesFDA
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Allura Xper FD20/10; Catalog numbers: 722029
Hazard: Possibility of the patient falling from the table related to the mattress used on the patient table.
February 26, 2025Medical DevicesFDA
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Allura Xper FD20 OR Table; Catalog numbers: (1) 722023, (2) 722035.
Hazard: Possibility of the patient falling from the table related to the mattress used on the patient table.
February 26, 2025Medical DevicesFDA
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Allura Xper FD20 Biplane OR Table; Catalog numbers: (1) 722020, (2) 722025.
Hazard: Possibility of the patient falling from the table related to the mattress used on the patient table.
February 26, 2025Medical DevicesFDA
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Allura Xper FD20 Biplane; Catalog numbers: (1) 722008, (2) 722013.
Hazard: Possibility of the patient falling from the table related to the mattress used on the patient table.
February 26, 2025Medical DevicesFDA
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Allura Xper FD20; Catalog numbers: (1) 722006, (2) 722012, (3) 722028.
Hazard: Possibility of the patient falling from the table related to the mattress used on the patient table.
February 26, 2025Medical DevicesFDA
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Allura Xper FD10/10; Catalog numbers: (1) 722005, (2) 722011, (3) 722027.
Hazard: Possibility of the patient falling from the table related to the mattress used on the patient table.
February 26, 2025Medical DevicesFDA
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Allura Xper FD10 - Catalog numbers: (1) 722003, (2) 722010, (3) 722026,
Hazard: Possibility of the patient falling from the table related to the mattress used on the patient table.
February 26, 2025Medical DevicesFDA
Spectranetics Corporation recalls Intact Vascular Tack Endovascular System, to treat vascular dissections with Tack implant(s) following angioplasty: (4F,
Hazard: Use 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.
February 19, 2025Medical DevicesFDA
Hologic, Inc recalls Brand Name: Sertera Biopsy Device Product Name: Sertera Biopsy Device Model/Catalog Number: Sertera-14 Software Versi
Hazard: Devices presented a condition in which the inner needle separated from the hub and produced a longer throw of the inner needle or dislodgement.
February 19, 2025Medical DevicesFDA
Murata Vios, Inc. recalls Vios Monitoring System Bedside Monitor, Model BSM2050, Software Version Numbers 1.54.20 and 1.56.00
Hazard: A premature failure condition was identified with the L2050R pulse oximeter SpO2 sensor that connects to the L2050G Vios chest sensor device. When a failure occurs, a Pulse Ox Sensor Off warning condition will be incorrectly displayed by the system.
February 19, 2025Medical DevicesFDA
Integra LifeSciences Corp. recalls Brand Name: MediHoney¿ Gel Product Name: MediHoney¿ Wound & Burn Dressing Gel Model/Catalog Number: 31815 Software Ve
Hazard: Potential that the induction seal is not completely sealed to the device tube packaging.
February 19, 2025Medical DevicesFDA
Exactech, Inc. recalls Alteon XLE Item Number / Product Description: 140-22-70 NV EHXL NTL LNR G00 22MM 140-28-50 NV EHXLNTRL LNR G0 28MM
Hazard: Due to the lack of the Ethylene Vinyl Alcohol (EVOH) barrier layer.
February 19, 2025Medical DevicesFDA
Exactech, Inc. recalls Novation XLE Item Number / Product Description: 140-22-70 NV EHXL NTL LNR G00 22MM 140-28-50 NV EHXLNTRL LNR G0 28MM
Hazard: Due to the lack of the Ethylene Vinyl Alcohol (EVOH) barrier layer.
February 19, 2025Medical DevicesFDA
Exactech, Inc. recalls AcuMatch XLE Item Number / Product Description: 140-28-27 AM EHXL 0¿ LNR G 28MM 140-32-27 AM EHXL 0¿ LNR G 32MM 140-
Hazard: Due to the lack of the Ethylene Vinyl Alcohol (EVOH) barrier layer.
February 19, 2025Medical DevicesFDA
Microbiologics Inc recalls Microbiologics Multi-Strain Human Papillomavirus (HPV) Verification Panel (Inactivated Pellet), REF 8235; in-vitro diagn
Hazard: Internal quality control procedures were not followed correctly for the testing/release of three lots of 8234/8235. This resulted in the release of products that should have failed and been discarded. The concentration of one target (HPV 16 L1) was low enough to cause QC failures, no detection, or invalid results on some instruments and assays.
February 19, 2025Medical DevicesFDA
Microbiologics Inc recalls Microbiologics Multi-Strain Human Papillomavirus (HPV) Control Panel (Inactivated Pellet), REF 8234; in-vitro diagnostic
Hazard: Internal quality control procedures were not followed correctly for the testing/release of three lots of 8234/8235. This resulted in the release of products that should have failed and been discarded. The concentration of one target (HPV 16 L1) was low enough to cause QC failures, no detection, or invalid results on some instruments and assays.
February 19, 2025Medical DevicesFDA
Elekta, Inc. recalls MOSAIQ Oncology Information System
Hazard: Image offsets calculated by oncology Information System software may be incorrect for Linear Accelerator (LINACs) not characterized at IEC61217 scale.
February 19, 2025Medical DevicesFDA
HF Acquisition Co LLC recalls Biological, Bio52 HealthFirst Mail In Monitoring System, 52 Tests, Item: 1003600. Biological, Bio12 HealthFirst Mail In
Hazard: Spore test strip monitoring system, designed for routine monitoring of sterilization processes, may have a printing error on the return envelope that may cause spore test results to be reported to the incorrect customer's account.
February 19, 2025Medical DevicesFDA
Angel Medical Systems, Inc. recalls Brand Name: The Guardian System Product Name: The Guardian Model/Catalog Number: Model AMSG3-E Product Description: The
Hazard: Device reaching End of Service prematurely.
February 19, 2025Medical DevicesFDA
Stryker Corporation recalls stryker Precision Thin, Catalog Number REF 2296-003-155; Micro Oscillating and Sagittal Blades
Hazard: Precision Thin blade attachments have a potential to be out of measurement specifications, preventing them from securely fitting into the compatible handpiece.
February 19, 2025Medical DevicesFDA
Stryker Corporation recalls stryker Precision Thin, Catalog Number REF 2296-003-108; Micro Oscillating and Sagittal Blades
Hazard: Precision Thin blade attachments have a potential to be out of measurement specifications, preventing them from securely fitting into the compatible handpiece.