Field Safety Notices - 23 - 27 May 2016

Summary List of field safety notices (FSNs) from medical device manufacturers from 23 - 27 May 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

ArjoHuntleigh: Akron Echo 2

05 April 2016

Trolleys and chairs

Model: Akron Echo 2 A5962, A5972

MHRA reference: 2016/003/017/701/015

BBI Solutions: SimpliRED D-Dimer

26 May 2016


Model: DSRK4

MHRA reference: 2016/005/023/601/007

ConMed: ThermoGard Dual Dispersive Electrodes

25 May 2016

Surgical, diathermy

MHRA reference: 2016/005/023/701/015

Depuy Synthes: Flexible Shaft Ø 8.0mm, L 360 mm

18 May 2016

Osteosynthesis, nails intramedullary

Model: Flexible Shaft Ø 8.0mm, L 360 mm for Extraction System for Solid Medullary Nails 351.430

MHRA reference: 2016/005/025/299/005

Edwards Lifesciences: Edwards Commander Delivery System

20 May 2016

Vascular cannula and catheters

Model: 9610TF23, 9610TF26, 9610TF29

MHRA reference: 2016/005/020/701/021

GE Healthcare Medical: Optima MR430s, MSK Extreme MR Scanner

FMI 60899

Magnetic resonance, equipment & accessories

MHRA reference: 2016/005/020/299/030

HeartWare: HeartWare Ventricular Assist System

24 May 2016

Implantable ventricular assist devices

Model: 1400, 1407XX

MHRA reference: 2016/005/024/291/012

Invacare: FOX

16 May 2016

Wheelchairs, powered

MHRA reference: 2016/004/028/701/014

Johnson & Johnson: ETHICON PHYSIOMESH™ Flexible Composite Mesh

25 May 2016

Implants, non-active, abdominal & hernia mesh

MHRA reference: 2016/005/025/701/005

LiNA: LiNA Fetal Scalp Blood Sampler

10 March 2016

Storage & collection devices

Model: 4201-BCI, 4201-BR

MHRA reference: 2016/003/011/601/004

Medfact Engineering: FIRMap catheter

03 May 2016

Therapy tissue ablation

MHRA reference: 2016/005/024/291/005

Medtronic: Coronary stent- Bare Metal

May 2016

Implants, non-active, coronary artery stents

MHRA reference: 2016/005/013/291/012

Medtronic: Midas Rex

# ® Sagittal Saws

May 2016

Surgical power tools

Model: ES300, ES300-R, ES310, ES310-R.

MHRA reference: 2016/005/023/299/018

One Lambda: AllSet+™ Gold SSP

06 May 2016

IVDs, haematology

MHRA reference: 2016/005/023/299/008

One Lambda: UniTray SSP HLA Typing Kits

06 May 2016

IVDs, immunology

MHRA reference: 2016/005/025/291/008

Randox: RX daytona plus - RX4040/RX4041

18 May 2016

IVDs, clinical chemistry

MHRA reference: 2016/005/020/601/004

Roche: Vancomycin: products see below under “Accessories”

13 May 2016

IVDs, bacteriology

Model: Antimicrobial Suscepitibility Testing

MHRA reference: 2016/005/023/701/013

Roche: ONLINE TDM Gentamicin 100 Tests, ONLINE TDM Gentamicin 100 Tests, ONLINE TDM Gentamicin Mod.

23 May 2016

IVDs, bacteriology

MHRA reference: 2016/005/025/071/001

Siemens: Stratus CS 200 Acute Care™ Diagnostics System

May 2016

IVDs, clinical chemistry

MHRA reference: 2016/005/026/601/004

Thermofisher: K671411-2

5 May 2016

IVDs, bacteriology

MHRA reference: 2016/005/005/601/003

X-spine: Calix Trials and Rasps

23 May 2016

Spinal implants

MHRA reference: 2016/005/024/601/001

Zimmer Biomet: Hip and Trauma Implant Screws

19 May 2016

Osteosynthesis, bone screws

MHRA reference: 2016/005/020/701/015

Zimmer: Cephalomedullary Femoral Nail

23 May 2016

Osteosynthesis, nails intramedullary

Model: Cephalomedullary Femoral Naillong 11.5mm X 30cm 130 CCD Left TI-6AL-4V; Cephalomedullary Femoral Nail - Long 13mm X 30cm 125 CCD Right TI-6AL-4V

MHRA reference: 2016/005/023/701/014

Published 1 June 2016