Field Safety Notice: 25 to 29 March

List of field safety notices (FSNs) from medical device manufacturers from 25 to 29 March.

From:
Medicines and Healthcare products Regulatory Agency
Published
1 April 2019
Last updated
2 April 2019 — See all updates
Message type:
Field safety notice
Issued:
1 April 2019

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

ALCIS: Dental Arch

21 February 2019

Dental appliances / instruments

Model: 2099-AS

MHRA reference: 2019/003/022/291/005

AngioDynamics: NanoKnife Single Electrode Probe

22 March 2019

Therapy tissue ablation

MHRA reference: 2019/003/028/291/011

Arjo: Arjo Disposable Flite Clip Sling

04 April 2019

Hoists and slings

MFA1000M-XL-L1

MHRA reference: 2019/003/019/601/001

BioFire Diagnostics: FilmArray® Blood Culture Identification (BCID) Pan

25 March 2019

IVDs, bacteriology

RFIT-ASY-0127 / RFIT-ASY-0126

MHRA reference: 2019/003/026/291/003

BIOMERIEUX: VITEK® 2: AST-N254, AST-N330, AST-N371 test kits

25 March 2019

IVDs, bacteriology

MHRA reference: 2019/003/022/291/010

Brainlab: RT Elements

11 March 2019

Radiotherapy planning and verification systems

MHRA reference: 2019/003/026/701/002

Buhlmann Laboratories: IBDoc, component: IBDoc Portal, version 3.1.9

21 March 2019

IVDs, clinical chemistry

MHRA reference: 2019/003/022/701/012

Covidien (Medtronic): Endo Clinch™ II Auto Suture™ Grasper, Endo Grasp™ Grasper

March 2019

Surgical Instruments, Articulated Holding

Endo Clinch™ II Auto Suture™ Grasper - 174317, Endo Grasp™ Grasper – 173030

MHRA reference: 2019/003/025/291/006

Christoph Miethke: Ventricular Catheter

25 March 2019

Cerebrospinal fluid drainage, external

FV074P

MHRA reference: 2019/003/027/291/006

Direct Healthcare Services: Dyna-Form Mercury Advance

15 March 2019

Mattresses - active/passive and overlays

MHRA reference: 2018/010/010/206/001

Draeger: Breathing circuits VentStar Helix

March 2019

Breathing system components

MHRA reference: 2019/003/027/291/003

EBR Systems: WiSE CRT Transmitter

21 March 2019

Implants, Active, Intracardiac (leadless)

4100

MHRA reference: 2019/003/025/291/009

GE Medical Systems: Discovery NM 630, Discovery NM/CT 670 CZT, Discovery NM/CT 670 DR, Discovery

NM/CT 670 ES, Optima NM/CT 640, NM 830, NM/CT 850, NM/CT 860, NM/CT 870 CZT, NM/CT 870 DR.

FMI 40885

Nuclear medicine

MHRA reference: 2019/003/027/291/007

Gambro (Baxter): U9000

25 March 2019

Dialysis, haemodialysis

112062

MHRA reference: 2019/003/025/291/023

Limacorporate: Physica ZUK All poly tibial components

25 March 2019

Joint prosthesis, knee

MHRA reference: 2019/003/025/701/013

Nobel Biocare

27 March 2019

Orthopaedic surgical instruments - Insertion/extraction tools

MHRA reference: 2019/003/028/291/003

Olympus: EVIS LUCERA DUODENOVIDEOSCOPE

29 March 2019

Endoscopes, flexible

TJF-260V / JF-260V

MHRA reference: 2019/003/027/291/018

Ortho-Clinical: VITROS XT 7600

21 March 2019

IVDs, clinical chemistry

MHRA reference: 2019/003/022/601/003

O-Two: o_two e700, o_two e600, and o_two e500

04 March 2019

Lung ventilators

MHRA reference: 2019/002/008/487/008

Philips: - MultiDiagnost Eleva

  • UroDiagnost Eleva
  • OmniDiagnost Classic
  • OmniDiagnost-Eleva

26 February 2019

X Ray, fluoroscopy systems

Model: - 708032: MultiDiagnost Eleva

  • 708033: UroDiagnost Eleva
  • 708034: MultiDiagnost Eleva with Flat Detector
  • 708035: MultiDiagnost Eleva with Flat Detector
  • 708036: MultiDiagnost Eleva
  • 708037: MultiDiagnost Eleva with Flat Detector
  • 708038: MultiDiagnost Eleva w Flat Detector
  • 70859: OmniDiagnost Classic
  • 708023: OmniDiagnost Classic
  • 708024: OmniDiagnost Classic
  • 708025: OmniDiagnost Classic
  • 708026: OmniDiagnost-Eleva
  • 708027: OmniDiagnost-Eleva
  • 708028: OmniDiagnost-Eleva

MHRA reference: 2019/003/027/291/004

R82: Wombat Living

27 March 2019

Supportive seating

Model: Wombat Living size 3

MHRA reference: 2019/003/027/291/017

Randox Laboratories: G-6-PDH Control Deficient and Normal

21 March 2019

IVDs, clinical chemistry

PD2617, PD2618

MHRA reference: 2019/003/027/601/003

Roche: ProCell II M 06908799190 N/A

cobas e 801 module 07682913001 N/A

cobas e 801 analytical unit 08454345001

12 March 2019

IVDs, clinical chemistry

MHRA reference: 2019/003/022/291/001

Roche: cobas p507, cobas p701 post-analytical unit

20 March 2019

IVDs, clinical chemistry

MHRA reference: 2019/003/025/701/017

Siemens: Cios Spin

27 February 2019

X Ray, fluoroscopy systems

MHRA reference: 2019/003/026/601/007

Siemens: Cios Alpha VA20 Systems

20 February 2019

X Ray, fluoroscopy systems

MHRA reference: 2019/003/021/601/006

Published 1 April 2019
Last updated 2 April 2019 + show all updates

  1. Corrected link to FSN for ProCell II M, cobas e 801 module and cobas e 801 analytical unit.

  2. First published.