Field safety notices - 26 to 30 November 2018
Summary List of field safety notices (FSNs) from medical device manufacturers from 26 to 30 November 2018
Overview
If you receive a field safety notice (FSN) from a manufacturer you must always act on it.
MHRA publishes the following for information only.
If you have a question about a particular FSN contact the manufacturer.
Latest FSNs
View the latest FSNs
Active Design FSN0001: CAPS II Seating System
12 November 2018
Wheelchairs, Manual
MHRA reference: 2018/011/028/291/016
Active Design FSN0002: CAPS II Seating System
12 November 2018
Wheelchairs, Manual
MHRA reference: 2018/011/028/291/017
ArjoHuntleigh: Minstrel
17 December 2018
Hoists and Slings
Model: HMA00XX-XX
MHRA reference: 2018/011/023/601/005
Baxter Healthcare: Gambro CWP800
16 November 2018
Dialysis, Haemodialysis
MHRA reference: 2018/011/026/487/001
Bone Support: CERAMENT Bone void filler, CERAMENT G, CERAMENT V
29 November 2018
Implant Materials, Bone Substitute
Model: A0210, A0450, A0451
MHRA reference: 2018/011/030/601/001
Elekta: Leksell GammaPlan®
July 2018
Radiotherapy
MHRA reference: 2018/011/023/487/004
GE Healthcare: Carescape R860
GEHC Ref# 34095
Lung ventilators
MHRA reference: 2018/011/026/487/018
Maquet (Getinge): Heat exchanger, heart-lung bypass
23 November 2018
Blood/fluid warmer unit Model: 70104.4054; 70105.4917
MHRA reference: 2018/011/026/487/017
Medtronic: Medtronic HeartWare™ HVAD™ Battery Charger
November 2018
Implantable ventricular assist devices
Model: 1600, 1610
MHRA reference: 2018/011/027/487/015
Medtronic FA854: Suction/Anticoagulation Assembly; Medtronic Perfusion Tubing Pack
November 2018
Infusion & Transfusion, Heart Lung Circuits
Model: Cardioplegia Tubing Packs
MHRA reference: 2018/011/029/291/003
Randox Laboratories: Calcium
30 November 2018
IVDs, Clinical Chemistry
Model: CA3871 CA8309 CA8021
MHRA reference: 2018/011/030/601/002
Randox Laboratories: Fructosamine Calibrators and Controls
26 November 2018
IVDs, Clinical Chemistry
Model: FR2993, FR2994, FR2996
MHRA reference: 2018/011/029/601/002
Randox Laboratories: RX Modena
28 November 2018
IVDs, Clinical Chemistry
Model: RX9000
MHRA reference: 2018/011/028/601/007
SiemensHealthcare: Sensis
20 November 2018
ECG
MHRA reference: 2018/011/029/601/009
Stryker: Delta Strike Plate IMN Instruments
23 November 2018
Tibial intramedullary nail
MHRA reference: 2018/011/025/701/001
Stryker: PneumoClear Heated High-Flow Tube Set
November 2018
Surgical Equipment, Minimal Access
MHRA reference: 2018/011/026/487/010
Waldemar Link GmbH and Co: MP-Prosthesis stem, XS-0, L=160
23 November 2018
Joint prosthesis, hip
MHRA reference: 2018/011/026/701/002