Field safety notices - 16 to 20 March 2015

List of field safety notices (FSNs) from medical device manufacturers from 16 to 20 March 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.

Latest FSNs

View the latest FSNs

Acumed: Acumed 1.5 mm and 2.3 mm MultiScrew depth gauges

26 February 2015

Device description: surgical instruments, implant

MHRA reference: 2015/003/016/081/003

iCAD: DynaLOC breast interventional planning software

12 February 2015

Device description: radiotherapy planning and verification systems

MHRA reference: 2015/002/017/081/009

Integra LifeSciences: Flowable wound matrix

16 March 2015

Device description: dermal substitutes, tissue scaffolds

Model: FDR301

MHRA reference: 2015/003/016/701/002

Medtronic: Dual chamber temporary pacemaker

18 March 2015

Device description: pacemakers, external

Model: 5392

MHRA reference: 2015/003/017/081/009

Microtek Medical: Vacuum source tubing set for EndoWrist stabilizer

11 March 2015

Device description: endoscopes, rigid

Model: 420187-05

MHRA reference: 2015/003/017/081/004

Ortho-Clinical Diagnostics: ORTHO VISION™ Analyzer

March 2015

Device description: IVDs, blood transfusion

MHRA reference: 2015/003/012/601/002

Philips Medical Systems DMC: Juno DRF

03 February 2014

Device description: X-ray, fluoroscopy systems

Model: 709020

MHRA reference: 2015/003/017/081/010

Roche Diagnostics: HCYS (Homocysteine enzymatic assay)

10 March 2015

Device description: IVDs, clinical chemistry

Model: HCYS (cobas c, COBAS INTEGRA® ) - Cat. No. 05385415190, Lot No.: 69781101 (Exp. 2015-04-30); HCYS (cobas c 701, 702) - Cat. No. 06542921190, Lot No.: 69781401 (Exp. 2015-04-30); HCYS (MODULAR <P>) - Cat. No. 05385377190, Lot No.: 69780301 (Exp. 2015-04-30).

MHRA reference: 2015/003/012/701/002

Siemens: Ysio Max; Luminos dRF Max; Luminos Agile Max; Uroskop Omnia Max

Reference: UI XP003/15/S

Device description: X-ray, digital acquisition systems

Model: 10762470; 10762471; 10762472; 10762473

MHRA reference: 2015/003/018/601/003

Smith & Nephew Orthopaedics: Birmingham Hip™ modular head & 12/14 modular taper sleeve

Reference: R-2015-02

Device description: joint prosthesis, hip

Model: BIRMINGHAM HIP™ Modular Head 38MM~62MM : 74222138, 74222140, 74222142, 74222144, 74222146, 74222148, 74222150, 74222152, 74222154, 74222156, 74222158, 74222160, 74222162.

MHRA reference: 2015/003/013/081/001

Synthes: Sleeve for ASLS , diameter 5.0mm, resorbable

13 March 2015

Device description: osteosynthesis, bone screws

Model: Sleeve for ASLS, diameter 5.0mm, resorbable; 08.025.044.01S

MHRA reference: 2015/003/016/081/014

Synthes GmbH: Aiming arm 125° for static distal locking and aiming arm 130° for static distal locking

18 March 2015

Device description: surgical instruments, implant

Model: 03.037.014: 03.037.013

MHRA reference: 2015/003/011/081/016

Terumo Europe: Terumo two-parts hypodermic syringe

Reference: FSN 1409 2015-03

Device description: injection devices

Model: SS+T02S1, SS+T05ES1, SS+T10ES1, SS+T20ES1

MHRA reference: 2015/003/012/081/007

Weinmann Emergency Medical Technology: Medumat with the blue test bag

03 March 2015

Device description: lung ventilators

MHRA reference: 2015/003/013/081/004

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