Alerts and recalls for drugs and medical devices

9th February 2020 By TSETadmin

Philips sterilizable defibrillator internal paddles (specific models) – may fail to deliver therapy if pre-use checks are not followed (MDA/2020/022)
Source: Alerts and recalls for drugs and medical devices for Medical device alert Published on 2020-07-23
Masks: type IIR from Cardinal Health – destroy affected lots (MDA/2020/021)
Source: Alerts and recalls for drugs and medical devices for Medical device alert Published on 2020-07-20
Spinal fixation system – risk of implant failure prior to completion of bone healing (MDA/2020/020)
Source: Alerts and recalls for drugs and medical devices for Medical device alert Published on 2020-07-10
Abbott Trifecta / Trifecta GT bioprosthetic aortic heart valves: cases of structural valve deterioration (SVD) (MDA/2020/019)
Source: Alerts and recalls for drugs and medical devices for Medical device alert Published on 2020-07-06
Philips HeartStart XL Defibrillator/Monitor – therapy selector switch may fail (MDA/2020/018)
Source: Alerts and recalls for drugs and medical devices for Medical device alert Published on 2020-06-30
Philips Respironics V60 ventilator – potential unexpected shutdown leading to complete loss of ventilation (MDA/2020/017)
Source: Alerts and recalls for drugs and medical devices for Medical device alert Published on 2020-06-29
Philips HeartStart MRx Monitor/Defibrillators - may fail to deliver therapy without alerting the user to a fault in the event of internal damage (MDA/2020/016)
Source: Alerts and recalls for drugs and medical devices for Medical device alert Published on 2020-06-17
Results from laboratory-based tests for COVID-19 antibodies using capillary blood sample collection kits may not be reliable (MDA/2020/015)
Source: Alerts and recalls for drugs and medical devices for Medical device alert Published on 2020-06-08
Pilling Clear Advantage aortic punch – risk of infection due to packaging failure (MDA/2020/014)
Source: Alerts and recalls for drugs and medical devices for Medical device alert Published on 2020-04-20
COVID-19: All haemofiltration systems including machines and accessories – serious risks if users don’t follow manufacturer instructions for set-up (MDA/2020/013)
Source: Alerts and recalls for drugs and medical devices for Medical device alert Published on 2020-04-10
Anaesthetic machines: off-label use during the COVID-19 pandemic (MDA/2020/012)
Source: Alerts and recalls for drugs and medical devices for Medical device alert Published on 2020-04-08
Spinal implant: All MAGEC Systems – supply suspended to the UK (MDA/2020/011)
Source: Alerts and recalls for drugs and medical devices for Medical device alert Published on 2020-04-01
Spinal implant: MAGEC System Model X rods – risk of failure in use (MDA/2020/010)
Source: Alerts and recalls for drugs and medical devices for Medical device alert Published on 2020-03-18
Tympanic thermometers – revision of the calibration frequency of Cardinal Health Genius 2 and Genius 3 models
Source: Alerts and recalls for drugs and medical devices for Medical device alert Published on 2020-02-27
Various Olympus duodenoscope models: do not use if elevator wires are frayed or damaged as these may cause lacerations to patients and users (MDA/2020/008)
Source: Alerts and recalls for drugs and medical devices for Medical device alert Published on 2020-02-27