Field safety notices - 14 November - 18 November 2016

Summary List of field safety notices (FSNs) from medical device manufacturers from 14 November - 18 November 2016


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: ARCHITECT Toxo IgM

14 November 2014

IVDs, viral microbiology

MHRA reference: 2016/011/015/701/016

Bayer: Medrad® IntegoPET Source Administration Sets

November 2016

Infusion & transfusion, administration sets

MHRA reference: 2016/011/010/291/009

B. Braun: Dialog+ Dialysis machines with SW 8.2A with option Adimea fitted

14 October 2016

Dialysis, haemodialysis

Model: Dialog+ - complete list to follow

MHRA reference: 2016/010/014/601/010

Depuy Synthes

11 November 2016

Surgical instruments, non-articulated cutting

Model: 352.044; 352.040

MHRA reference: 2016/011/016/299/014

Handicare: Vertical Support

1 November 2016

Hoists and slings

Model: 50400242, 50400190, 50400235

MHRA reference: 2016/011/007/291/004

IMPAC Medical: Monaco RTP System

October 2016

Radiotherapy planning and verification systems

MHRA reference: 2016/011/014/701/006

Medline International: Sterile Procedure Trays

26 October 2016

Surgical devices, non-powered

MHRA reference: 2016/011/004/701/018

Medtronic: Affinity Fusion™ Oxygenator with Integrated Arterial Filter and CVR

November 2016

Infusion and transfusion, heart lung circuits

Model: BB841

MHRA reference: 2016/011/016/299/023

Research Instruments: EZ-Tip

3 October 2016

Laboratory equipment associated with IVF, cells, tissues

MHRA reference: 2016/010/003/701/006

Siemens: AXIOM Artis systems with SW version VB35E

27 October 2016

X-ray, fluoroscopy systems

MHRA reference: 2016/011/016/601/007

Siemens: SOMATOM Definition AS and SOMATOM Definition Flash

4 October 2016

Computed tomography

Model: 08098027 (SOMATOM Definition AS), 10430603 (Flash)

MHRA reference: 2016/011/016/601/010

Siemens: Business Area Advanced Therapies: Artis Q systems with SW version VD11

27 October 2016

X Ray, Fluoroscopy dystems

Model: all Artis Q systems with SW version VD11 and Gigalix X-ray tubes

MHRA reference: 2016/011/016/601/005

Siemens: Business Area Advanced Therapies: Artis zee systems with SW version VC21C, VD11

27 October 2016

X Ray, Fluoroscopy systems

Model: Artis zee systems with SW version VC21C, VD11 and MegalixCat + X-ray tubes

MHRA reference: 2016/011/016/601/008

Ulrich: Surgical Technique uCentum - Locking Screw


Osteosynthesis, bone screws

Model: CS 3801-01 – Locking Screw

MHRA reference: 2016/011/016/299/011

Ulthera: Cellfina System

14 November 2016

Surgical devices, non-powered

MHRA reference: 2016/011/015/701/007

Various: heater/cooler units

11 November 2016

Blood/fluid warming systems

MHRA reference: 2014/007/016/081/003

Wright Various

8 November 2016

Sterilization, healthcare

MHRA reference: 2016/011/011/291/016

Published 21 November 2016