Medical device alerts archived in December 2021
Following our latest review of medical device alerts, we have archived the ones listed below.
| Reference | Title |
|---|---|
| External Pacemakers: Models - E4162, E4164, E4165 and E4166 (manufactured by APC Medical Ltd) | |
| Boston Scientific Ltd: Vitality and Assure implantable cardioverter defibrillator (ICD) families and Contak Renewal cardiac resynchronisation therapy defibrillator (CRT-D) families | |
| Implantable Pacemakers: Medtronic Kappa庐 600/700/900 Series IPGs; Medtronic Sigma庐 100/200/300 Series IPGs. | |
| Teligen implantable cardioverter defibrillators (ICDs) and Cognis cardiac resynchronisation therapy defibrillators (CRT-Ds) 鈥� specific models. Manufactured by Boston Scientific. | |
| Pacemaker. Reply and Esprit models that have been interrogated with programmer containing software version 2.24. Manufactured by Sorin CRM. | |
| Dual Chamber Pacemakers. Medtronic models: Kappa 600, 700, 800 and 900; EnPulse; Adapta; Versa; Sensia; Relia. Vitatron models: E50A1, E60A1 and G70A1 | |
| Subcutaneous implantable cardioverter defibrillator (S-ICD): SQ-RX庐 pulse generator, model 1010. Manufactured by Cameron Health. | |
| Implantable cardioverter defibrillator (ICD). Paradym, model numbers: VR 8250, DR 8550, CRT-D 8750 and 8770, VR 9250, DR 9550, CRT-D 9750 and 9770. | |
| Implantable Pulse Generators (IPGs) 鈥� Neurostimulators. Eon Mini鈩� (Model 65-3788) and Brio鈩� (Model 65-6788). Manufactured by St Jude Medical. | |
| Implantable pacemakers manufactured by Medtronic. EnRhythm庐: Model P1501DR, EnRhythm MRI鈩� SureScan: Model EMDR01 IPG | |
| Implantable cardioverter defibrillators (ICD). EnTrust VR/DR/AT. Models: D153ATG, D153DRG, D153VRC, D154ATG, D154DRG, and D154VRC. Manufactured by Medtronic. | |
| External pacemaker used with temporary endocardial pacing leads or epicardial pacing wires MICRO-PACE 4580. Manufactured by Pace Medical and distributed in the UK by APC Cardiovascular. | |
| External pacemaker: MICRO-PACE REF 4580. Manufactured by Pace Medical and distributed in the UK by APC Cardiovascular. | |
| External pacemaker: MICRO-PACE REF 4580.Manufactured by Pace Medical and distributed in the UK by APC Cardiovascular. | |
| V60 ventilator 鈥� potential for unexpected shutdown | |
| Aisys and Aisys CS2 anaesthesia devices with Et Control option and software versions 11, 11SP01 and 11SP02 鈥� risk of patient awareness due to inadequate anaesthesia | |
| Rocket and NuSurgix fetal blood sampling (FBS) amnioscopes and FBS kits 鈥� stop using ethyl chloride spray during the fetal blood sampling procedure with these devices |
Updates to this page
Published 3 December 2021