Field safety notices - 7 to 11 December 2015

List of field safety notices (FSNs) from medical device manufacturers from 7 to 11 December 2015

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.

See more information on what an FSN is and why it’s important.

Latest FSNs

View the latest FSNs

Abbott: Absorb and Absorb GT1 bioresorbable vascular scaffold system

7 December 2015

Implants, non-active, coronary artery stents

MHRA reference: 2015/012/002/291/003

Biomet Orthopaedics: A.L.P.S. 4.0mm cancellous locking screw

20 November 2015

Osteosynthesis, bone screws

MHRA reference: 2015/012/001/292/002

Biomet 3i UK, Ltd: LOCATOR® abutments (LOA002)

9 December 2015

Implants, dental

MHRA reference: 2015/012/010/292/016

Beckman Coulter: MicroScan Pos Combo and MicroScan Pos Breakpoint Combo panels

8 December 2015

IVDs, bacteriology

Model: B1017-201, B1017-211, B1017-214, B1016-161, B1016-172, B1016-174, B1017-202, B1017-206, B1016-152, B1016-164

MHRA reference: 2015/012/009/601/008

Boston Scientific: ACUITY™ lead delivery system guide catheters - ACUITY™ Pro

November 2015

Vascular cannula and catheters

MHRA reference: 2015/012/007/291/014

Ethicon: Gynecare Thermachoice III catheter

2 December 2015

Therapy tissue ablation MHRA reference: 2015/012/003/291/006

Elekta Impac Medical: MOSAIQ

FCA-IMS-0012 Radiotherapy

MHRA reference: 2015/012/007/291/009

Mast Group: Mast Augmentin 32μg 96 well pre-poured susceptibility test plate

C5668

IVDs, bacteriology

Model: MPM-AUG32

MHRA reference: 2015/012/008/601/005

Medasil Surgical Limited: Medasil airway (Guedel type)

CCR 181

Airway devices

MHRA reference: 2015/011/027/701/001

Molnlycke Health: ProcedurePak containing MeCoBo swabs

4 December 2015

Surgical devices, non-powered

MHRA reference: 2015/012/007/291/015

Pyng Medical: MATResponder tourniquet, MATCombat tourniquet

1 September 2015

Surgical equipment, tourniquets

MHRA reference: 2015/012/010/292/012

Siemens Healthcare: All applicable Siemens MR systems with superconducting magnets

3 December 2015

Magnetic resonance, equipment and accessories

MHRA reference: 2015/012/004/601/005

Synthes Selzach: SynReam medullary reamer head diameter 13.5mm

4 December 2015

Surgical instruments, implant

Model: 352.135

MHRA reference: 2015/012/009/292/003

Synthes Mezzovico: universal femoral nails

8 December 2015

Osteosynthesis, nails intramedullary

Model: 272.136, 274.220, 274.020, 274.130

MHRA reference: 2015/012/009/292/010

Venus Concept: Venus Versa

3 November 2015

Intense pulse light source

Model: VE102407

MHRA reference: 2015/011/009/292/010

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