Field Safety Notice - 24 September to 28 September

List of field safety notices (FSNs) from medical device manufacturers from 24 September to 28 September

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

B Braun: 220-240V Unit Cable (power cord)

17 September 2018

Infusion systems

Model: 34502718

MHRA reference: 2018/009/020/601/003

Bayer: Low Volume IV Filter / BC 693

19 September 2018

Infusion & transfusion, administration sets

MHRA reference: 2018/009/019/291/004

Beckman Coulter: Kaluza C Software

21 September 2018

IVDs, cytopathology & histopathology

MHRA reference: 2018/009/025/601/006

CooperSurgical: Single-Use, Colpo-Pneumo Occluder

04 September 2018

Surgical instruments, minimal access

Model: Single-Use, Colpo-Pneumo Occluder - CPO-6

MHRA reference: 2018/009/024/081/019

Endologix: Ovation Abdominal Stent Graft System Platform

26 September 2018

Implants, non active, endoprostheses for aortic aneurysms

Model: TV-AB2080-D, TV-AB2380-D, TV-AB2680-D, TV-AB2980-D, TV-AB3480-D, TV-AB2080-I, TV-AB2380-I, TV-AB2680-I, TV-AB2980-I, TV-AB3480-I

MHRA reference: 2018/009/027/701/037

GE Healthcare: Millennium MG, Millennium MC, Millennium MYOSIG

FMI 40878

Nuclear medicine, gamma camera systems & accessories

MHRA reference: 2018/009/026/228/004

Gambro (Baxter): AK 98

25 September 2018

Dialysis, haemodialysis

Model: 15244, 115248, 115249, 115250, 955106, 955403, 955404

MHRA reference: 2018/009/014/000/009

Heraeus: COPAL® knee moulds

13 July 2018

Bone cement and tools

MHRA reference: 2018/007/017/291/003

Orthofix: DRILL BITS

24 September 2018

Surgical power tools

MHRA reference: 2018/009/026/701/019

RaySearch Laboratories: RayStation

21 September 2018

Radiotherapy planning and verification systems

Model: RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6 and RayStation 7

MHRA reference: 2018/009/025/701/011

Robinson Healthcare: Instrapac

14 September 2018

Surgical instruments, articulated holding

MHRA reference: 2018/009/019/601/006

Siemens: ARTIS pheno

06 September 2018

X ray, fluoroscopy systems

MHRA reference: 2018/009/024/601/001

Smiths Medical: Portex® Bivona® Inner Cannula Tracheostomy Tube

11 September 2018

Airway devices

Model: BRC270, BRC275, BRC280, BRC285, BRC290

MHRA reference: 2018/009/021/291/006

Stryker: Stryker Model 8001 Altrix

September 2018

Heating, patient, electrical pads & blankets

MHRA reference: 2018/009/017/000/007

Teleflex: CrystalClear Plus RUSCH CARE CrystalClear (PVC) Tracheostomy Cannula (no Cuff) - Set RUSCH CrystalClear (PVC) Tracheostomy Cannula (Cuffed) RUSCH CrystalClear (PVC) Tracheostomy Cannula (no Cuff)

21 September 2018

Airway devices

MHRA reference: 2018/009/024/081/005

Updates to this page

Published 1 October 2018