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 FSN-POZ-004-2018

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

23 November 2018

Joint prosthesis, hip

MHRA reference: 2018/011/026/701/002

Published 4 December 2018