Field safety notices - 7 to 10 April 2015

List of field safety notices (FSNs) from medical device manufacturers from 7 to 10 April 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

BAG Health Care: HISTO SPOT® stringent wash buffer

23 March 2015

Device description: IVDs, immunology

Model: HISTO SPOT® Stringent Wash Buffer (726093)

MHRA reference: 2015/004/007/701/005

BIOMERIEUX: VITEK® 2 antimicrobial susceptibility test kit

8 April 2015

Device description: IVDs, bacteriology

Model: VITEK® 2 antimicrobial susceptibility test kit (AST-YS01, AST-YS06, AST-YS07) (22108, 412610, 414967)

MHRA reference: 2015/004/009/292/014

Biomet Spine LLC: Torque Handle

12 March 2015

Device description: surgical instruments, implant

Model: Aspen/Alpine and Lineum torque handle

MHRA reference: 2015/004/002/291/008

Cellnovo Ltd: Cellnovo insulin infusion system

02 April 2015

Device description: infusion & transfusion, administration sets

Model: 7000081

MHRA reference: 2015/003/026/601/013

DePuy International

March 2015

Device description: joint prosthesis, knee

Model: LCS COMPLETE RPS femoral and the LCS COMPLETE RPS insert

MHRA reference: 2015/003/009/121/010

DIAsource Immunoassays: 11-Desoxycortisol-RIA-CT

8 April 2015

Device description: IVDs, clinical chemistry

MHRA reference: 2015/004/009/701/003

Edwards Lifesciences: Fem-Flex II™ femoral access cannula

31 March 2015

Device description: vascular cannula and catheters

Sizes 8, 10, 12 French

MHRA reference: 2015/004/001/071/006

Elekta: Precise Series Linac

Ref: 200 01 103 079

Device description: radiotherapy

Model: 153546

MHRA reference: 2015/001/002/601/004

GE Medical Systems: GE MR Systems

Ref: 60878

Device description: magnetic resonance, equipment and accessories

Model: various models

MHRA reference: 2015/004/007/701/008

Kenex (Electro-Medical): Kenex radiation shield installed with GEHC systems

31 March 2015

Device description: X-ray, protective equipment

Model: Kenex Suspension installed with radiation shield and/or lamp with model numbers: E03971AA ;E03981AA; E30421AA; E30431AA; E30591CA; E30591HD; E30591HL; E30591EB; E30511P; E30591AB; E30591B; E30591C; E30591A; E30591RR; E30591CB; E30591E; E33591PA; E33591PC

MHRA reference: 2015/004/007/701/006

LAAx: TIGERPAW System II

25 March 2015

Device description: implants, non-active, cardiac appendage and septal defect occluders / plugs

Model: C-TP-1507 and C-TP-1509

MHRA reference: 2015/004/007/071/010

Leica Biosystems: Ki67-MM1

10 April 2015

Device description: IVDs, cytopathology & histopathology

Model: Ki67-MM1 bond ready to use (PA0118), Ki67-MM1 concentrate (KI67-MM1-L-CE), Ki67-MM1 concentrate (KI67-MM1-L-CE-S).

MHRA reference: 2015/004/002/601/003

Ortho-Clinical Diagnostics: enGen™ Laboratory Automation Systems

April 2015

Device description: IVDs, clinical chemistry

Model: 6802883

MHRA reference: 2015/004/007/601/004

Randox Laboratories: Homocysteine

26 March 2015

Device description: IVDs, clinical chemistry

Model: HY4036

MHRA reference: 2015/004/002/601/009

Siemens Healthcare Diagnostics

April 2015

Device description: IVDs, clinical chemistry

Model: Dimension EXL® with LM

MHRA reference: 2015/004/007/601/002

Thermo Fisher Scientific: TCAutomation™ / enGen™ laboratory automation system

09 April 2015

Device description: IVDs, clinical chemistry

Model: TCA Recapper Cap, Rack Entry and Exit Module, Rack Exit Module, Recapper Module (230V), Recapper Module (11 OV), Storage Rack Slim, Storage Rack

MHRA reference: 2015/004/007/701/009

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