Field Safety Notices - 29 August - 2 September 2016

Summary List of field safety notices (FSNs) from medical device manufacturers from 29 August - 2 September 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

Biomet: Left MD Tibial Jig Tail Optilock

31 August 2016

Osteosynthesis, bone plates

MHRA reference: 2016/008/031/701/013

Cascade Designs: Cascade Designs Inc. / Varlite

19 August 2016

Pressure relief cushions

MHRA reference: 2016/009/001/291/018

Covidien / Medtronic: Puritan Bennett 980 ventilator

4 August 2016

Lung ventilators

MHRA reference: 2016/002/001/701/018

Hamilton Bonaduz AG: HAMILTON-MR1 ventilators

18 August 2016

Lung ventilators

MHRA reference: 2016/008/016/299/023

Human Care: Human Care Roomer S and Altair overhead lift

8 July 2016

Hoists and slings Model: Human Care Roomer S and Altair 55200-EU/AU/GB/NA/JP, 55210- EU/AU/GB/NA/JP, 55220- EU/AU/GB/NA/JP, 55300- EU/AU/GB/NA/JP

Human Care Roomer S and Altair

MHRA reference: 2016/008/030/291/018

Implant Direct Sybron Manufacturing: InterActive® Implant Open-Tray Transfer Narrow

19 May 2016

Implants, dental

Model: 6534-08N

MHRA reference: 2016/008/031/601/001

Kymco: Mini Comfort

25 July 2016

Scooters, powered

Model: Mini Comfort EQ20CG

MHRA reference: 2016/008/011/601/002

Maquet: Maquet Heater and Maquet heater/cooler systems

22 August 2016

Blood/fluid warming systems

Model: HU35, HCU20, HCU30, HCU40

MHRA reference: 2016/008/025/291/011

Novarad Corporation: NovaPACS

12 August 2016

Picture archiving and communication

MHRA reference: 2016/008/030/601/004

Otto Bock HealthCare: ProCarve

24 August 2016


Model: 3R2 ProCarve Knee Joint, 1E2 ProCarve Foot Standard, 1E2=1

MHRA reference: 2016/008/025/291/001

Sequent Medical: VIA 27 microcatheter

25 August 2016

Vascular cannula and catheters Model: FG27154-01

MHRA reference: 2016/008/025/291/022

Siemens: IMMULITE/IMMULITE 1000 and IMMULITE 2000/2000 XPi CMV (IgM)

August 2016

IVDs, clinical chemistry Model: LKCM1 (SMN# 10381296), LKCM1 (D)(SMN# 10370301), L2KCM2 (SMN# 10381320), L2KCM2 (D) (SMN# 10370302) MHRA reference: 2016/008/031/601/002

Spacelabs Healthcare: Xhibit Telemetry Receiver & Xhibit Central Station

25 August 2016

Monitors, patient

Model: Xhibit Telemetry Receiver & Xhibit Central Station 96280 & 96102

MHRA reference: 2016/009/001/291/004

Sorin: Perceval sutureless aortic heart valve

26 August 2016

Implants, non-active, cardiovascular Model: PVS21, PVS23, PVS25, PVS27

MHRA reference: 2016/008/030/291/005

Stryker: Scorpio Patella assembly instrument


Orthopaedic surgical instruments - Insertion/extraction tools

Model: 3182-1000

MHRA reference: 2016/008/010/701/014

Topcon: PASCAL Synthesis (532/577) & Twinstar (577/638)

5 July 2016

Therapy, lasers Model: Synthesis

MHRA reference: 2016/008/030/291/037

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