Field Safety Notice - 24 April to 28 April 2017

Summary List of field safety notices (FSNs) from medical device manufacturers from 24 - 28 April 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

AMO Uppsala: Healon, Healon GV, Healon 5 Pro, Healon Pro

April 2017

Implants, non active, intraocular

Model: 10200011, 10200012, 10200014, 10201012, 10201014, 10202014, 10270012, 10270015

MHRA reference: 2017/004/020/701/018

Autonomic Technologies: Pulsante SPG Microstimulator System

07 April 2017

Implants, active, leads, neuro

Model: NS-100, RC-200, SI-100-E, SI-110-E, SI-120-E, LB-100-E, PS-100

MHRA reference: 2017/004/004/299/008

Beckman Coulter: Access BR Monitor

18 April 2017

IVDs, clinical chemistry

Model: Not Applicable

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

Beckman Coulter: Synchron Systems Cholesterol, Creatinine, HDL Cholesterol, Lactate, Triglyceride, Uric Acid and Salicylate Reagents

18 April 2017 - FA-29156

IVDs, clinical chemistry

MHRA reference: 2017/004/020/601/007

Carl Zeiss: VisuMax with Treatment-Pack and accessories

23 January 2017

Therapy, lasers

Model: VisuMax with Treatment-Pack and accessories

MHRA reference: 2017/004/025/299/027

Cook Medical: See Comments Section

2017FA0005

Sutures

Model: Pereyra-Raz Ligature Carrier™ Pereyra Ligature Carrier '75® Stamey Needle

MHRA reference: 2017/004/027/701/009

Cook Medical: Stamey Needle

24 April 2017

Sutures

MHRA reference: 2017/004/026/701/006

Medical Intelligence Medizintechnik:

FCA-MI-0001

Radiotherapy

Model: Intelligence Mediz

MHRA reference: 2017/004/027/701/020

One Lambda: LABScreen® Multi

19 April 2017

IVDs, immunology

MHRA reference: 2017/004/021/701/015

Ortho Solutions: OXFORD/ OXBRIDGE AFN END CAP 10mm x 5mm to 12mm x 10mm

19 April 2017

Osteosynthesis, nails intramedullary

Model: OS331100-07

MHRA reference: 2017/004/021/601/009

PEROUSE MEDICAL: Dolphin Inflation Device/Caliber Inflation Device

FSCA-PM-2017-01

Vascular cannula/catheter accessories

MHRA reference: 2017/004/025/701/012

Randox Laboratories: Liquid Urine Control - Level 3

20 April 2017

IVDs, clinical chemistry

Model: UC5075, Liquid Urine Control - Level 3

MHRA reference: 2017/004/026/601/012

Spacelabs: 99999, Arkon Anesthesia Delivery System

13 April 2017

Anaesthetic machines & monitors

MHRA reference: 2017/004/025/701/014

Siemens: ADVIA Centaur Insulin

CC 17-10

IVDs, clinical chemistry

Model: SMN 10310439 SMN 10310438

MHRA reference: 2017/004/010/601/005

Stryker: Exeter V40 Femoral Stems (44mm, No. 0, L. 150mm)

RA2017-011

Joint prosthesis, hip

Model: Exeter

MHRA reference: 2017/004/021/701/006

bioMérieux: VITEK® 2 Identification / Antimicrobial Susceptibility Test Cards referenced in Appendix A

20 April 2017

IVDs, bacteriology

MHRA reference: 2017/004/025/291/012

Published 2 May 2017