Class IOngoingZ-1145-2025
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Allura Xper FD20 Biplane
Possibility of the patient falling from the table related to the mattress used on the patient table.
PHILIPS MEDICAL SYSTEM…Feb 26, 2025
Class I recalls
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 553–564 of 595 recalls
Class IOngoingZ-1144-2025
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Allura Xper FD20
Possibility of the patient falling from the table related to the mattress used on the patient table.
PHILIPS MEDICAL SYSTEM…Feb 26, 2025
Class IOngoingZ-1143-2025
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Allura Xper FD10/10
Possibility of the patient falling from the table related to the mattress used on the patient table.
PHILIPS MEDICAL SYSTEM…Feb 26, 2025
Class IOngoingZ-1142-2025
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Allura Xper FD10 - Catalog numbers: (1) 722003
Possibility of the patient falling from the table related to the mattress used on the patient table.
PHILIPS MEDICAL SYSTEM…Feb 26, 2025
Class IOngoingZ-1070-2025
Spectranetics Corporation recalls Intact Vascular Tack Endovascular System
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 devi…
Spectranetics Corporat…COFeb 26, 2025
Class IOngoingZ-1117-2025
Max Mobility LLC recalls Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DCK use in conjunct…
Due to faulty circuit board in speed control remote use in conjunction with a wheelchair power assist, their is a potential for lost of control of device potentially resulting in minor and major injuries.
Max Mobility LLCTNFeb 19, 2025
Class IOngoingZ-1116-2025
Max Mobility LLC recalls Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DC use in conjuncti…
Due to faulty circuit board in speed control remote use in conjunction with a wheelchair power assist, their is a potential for lost of control of device potentially resulting in minor and major injuries.
Max Mobility LLCTNFeb 19, 2025
Class IOngoingZ-1074-2025
Getinge Usa Sales Inc recalls Vaporizer Sevoflurane
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.…
Getinge Usa Sales IncNJFeb 19, 2025
Class IOngoingZ-1071-2025
Olympus Corporation Of The Americas recalls Olympus Single Use Guide Sheath Kits with the following product descriptions and model…
Potential for the radiopaque tip of the guide sheath component to disassociate and fall off into the patient.
Olympus Corporation of…PAFeb 19, 2025
Class IOngoingZ-1047-2025
ROi CPS LLC recalls regard Item Number: 830106006
There is a potential for the Inline Controller to be using the spring out of specification causing a loss of positive pressure resulting in the Neo-Tee Resuscitator and/or Circuit will not reach the high and low ends of…
ROi CPS LLCMOFeb 12, 2025
Class IOngoingZ-1019-2025
Fresenius Kabi USA, LLC recalls Ivenix Infusion System (IIS)
Large 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.…
Fresenius Kabi USA, LL…MAFeb 12, 2025
Class IOngoingZ-0992-2025
MEDLINE INDUSTRIES, LP - Northfield recalls Medline General Surgery Tray kits: 1) ARTERIAL LINE TRAY
The catheter subassembly in the Integrated Arterial Catheter was manufactured with excess material on the catheter hub.
MEDLINE INDUSTRIES, LP…ILFeb 5, 2025