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