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