Field Safety Notice - 16 to 20 October 2017

Summary List of field safety notices (FSNs) from medical device manufacturers from 16 to 20 October 2017.

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

Abbott: Alinity i Processing Module

11 October 2017

IVDs, clinical chemistry

MHRA reference: 2017/010/013/701/028

Bard: BARD® MAX-CORE® Disposable Core Biopsy Instrument

FA2017-50

Surgical Instruments, Minimal Access

MHRA reference: 2017/010/012/601/002

Beckman Coulter: Access BR Monitor

12 September 2017

IVDs, clinical chemistry

MHRA reference: 2017/004/020/601/009

BIOMERIEUX

12 October 2017

IVDs, bacteriology

Model: BacT/ALERT® BPN Culture Bottle

MHRA reference: 2017/010/016/291/017

BIOMERIEUX: VITEK® 2 System

12 October 2017

IVDs, bacteriology

MHRA reference: 2017/010/017/291/006

BIOMERIEUX: VITEK® 2 Gram-Positive (GP) Identification (ID) Test Kit

17 October 2017

IVDs, bacteriology

MHRA reference: 2017/010/018/291/005

Coloplast: Duowire™ Bi-Flex

16 October 2017

Surgical instruments, minimal access

MHRA reference: 2017/010/019/000/001

CooperSurgical: 2MHz WATERPROOF OB PROBE

6 October 2017

Monitors, foetal

Model: SDW

MHRA reference: 2017/010/013/291/002

Diagnostica Stago: (STA) Néoplastine CI (Plus) 2 and 5

17 October 2017

Coagulation

MHRA reference: 2017/010/018/701/013

Fisher & Paykel: RT021 Catheter Mount

17 October 2017

Breathing systems components

Model: RT021

MHRA reference: 2017/010/012/291/005

Fisher & Paykel: RT443 Circuit Adult Homecare

17 October 2017

Breathing systems components

Model: RT443

MHRA reference: 2017/010/012/291/005

Manquet: HANAULUX 2000, HANAULUX 3000, XTEN series

September 2017

Lamps & lights

Model: HLX 2004-5 DF, HLX 3004-5 DF, XTEN DF

MHRA reference: 2017/009/026/291/011

Medivance: Arctic Sun® Temperature Management System

FA2017-14

Heating, patient, electrical pads & blankets

Model: Arctic Sun® Temperature Management System

MHRA reference: 2017/008/004/701/010

Permobil AB

6 October 2017

Wheelchairs, powered

Model: C300, C350, C400 and C500 with seats Corpus II, Corpus II LR, Corpus KB and Base Only

MHRA reference: 2017/009/004/701/002

Riverpoint Medical: Arena Alpha (OrthoButton AL)

11 October 2017

Ligaments, tendons and anchors

Model: D201028 (OBAL-80)

MHRA reference: 2017/010/012/601/004

Schiller

09 January 2017

ECG

Model: CARDIOVIT AT-102 plus 0.075000

MHRA reference: 2017/010/016/291/014

Siemens: DM FT4L, TSHL, SIRO DV CTNI, MMB, TSH

October 2017

IVDs, clinical chemistry

MHRA reference: 2017/010/018/601/002

St. Jude Medical: Implantable Pulse Generators (IPGs)

12 September 2017

Implants, active, stimulators, neuro

Model: Implantable Pulse Generators (IPGs)

MHRA reference: 2017/009/013/291/030

Surgical Innovations: Yelloport Plus

30 August 2017

Surgical instruments, minimal access

Model: YA512STSA

MHRA reference: 2017/010/014/601/001

Surgical Innovations: YelloPort 10.5/5.5 S/Use Flip-Top

29 September 2017

Surgical instruments, minimal access

Model: YelloPort 10.5/5.5 S/Use Flip-Top - 575019S

MHRA reference: 2017/010/016/601/006

Surgical Innovations: Yelloport 10.5/12.5 Valve Single-Use

10 October 2017

Surgical instruments, minimal access

Model: Yelloport 10.5/12.5 Valve Single-Use - 580004S

MHRA reference: 2017/010/016/601/008

Thermofisher Scientific: Oxoid Mueller – Hinton Agar (Prepared Media)

13 October 2017

IVDs, bacteriology

Model: PO0152A

MHRA reference: 2017/010/016/601/004

Published 24 October 2017