Field Safety Notice - 25 to 29 September 2017

Summary List of field safety notices (FSNs) from medical device manufacturers from 25 to 29 September 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

Bio-Rad: MONOLISA™ HCV Ag-Ab ULTRA V2

24 March 2017

IVDs, viral microbiology

MHRA reference: 2017/009/025/291/007

Biomet: Various kits (see recall notice for details)

11 July 2016

Implants, reconstructive, body contouring

Model: Anticoagulant Citrate Dextrose Solution

MHRA reference: 2016/007/022/701/012

Carl Zeiss: INTRABEAM PRS 500

25 August 2017

Radiotherapy

MHRA reference: 2017/009/021/291/006

Christoph Miethke: proSA Tool Set

19 September 2017

Implants, non active, hydrocephalus shunt

Model: FV792T

MHRA reference: 2017/009/025/701/003

Elekta

September 2017

Radiotherapy planning and verification systems

Model: ERGO++ and ERGO Localizer

MHRA reference: 2017/009/022/701/017

Exactech: Tibial Tray, Offset; Offset Spine Stiffener Screw

19 September 2017

Joint prosthesis, knee

MHRA reference: 2017/009/021/701/005

HMT Medizintechnik: see attached lists

28 August 2017

Blood/fluid warming systems

Model: siehe angehängte Liste

MHRA reference: 2017/009/027/701/014

Integra: CUSA Clarity (Footswitch)

25 September 2017

Surgical, diathermy

Model: C7000 (footswitch only)

MHRA reference: 2017/009/027/701/012

MEDICREA: PASS OCT/ Pedicle screwdriver shaft A17210100

13 July 2017

Orthopaedic surgical instruments - Insertion/extraction tools

MHRA reference: 2017/009/020/291/003

Medtronic: Neuray® Neurosurgical Patties and Strips; Merocel® Neurosurgical Patties and Packing

September 2017

Basic dressings, absorbents, swabs, procedure packs

Model: Neuray: 8003097, 8003098, 8003099, 8004000, 8004001 , 8004002, 8004003, 8004004, 8004005, 8004006, 8004007, 8004008, 8004009, 8004050, 8004051, 8004052, 8004053, 8004054, 8004055, 8004056, 8004057 Merocel: 300501, 300503, 300505, 300506, 300507, 300509, 300510, 300514, 300515, 400611

MHRA reference: 2017/009/025/291/011

Molnlycke Health Care: See attached Product Table

22 September 2017

Surgical devices, non-powered

MHRA reference: 2017/009/022/291/024

Siemens

September 2017

IVDs, clinical chemistry

Model: Handheld Barcode reader

MHRA reference: 2017/009/022/601/009

TEC COM GmbH Gesellschaft für Technik, Technologie und Vermarktung

2 August 2017

Blood/Fluid warming systems

MHRA reference: 2017/009/025/291/006

W.L. Gore & Associates: Conformable GORE® TAG® Thoracic Endoprosthesis

September 2017

Implants, non active, endoprostheses for aortic aneurysms

Model: TGE212110

MHRA reference: 2017/009/025/291/009

Zimmer: Custom Rotating Hinged Knee

20 September 2017

Joint prosthesis, knee

MHRA reference: 2017/009/022/291/005

Updates to this page

Published 2 October 2017