Field safety notices 2 to 6 March 2015
List of field safety notices (FSNs) from medical device manufacturers from 2 to 6 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
You can see copies of field safety notices in our filecamp folder.
Abbott: ARCHITECT Anti-HBc II
24 February 2015
Device description: IVDs, clinical chemistry
Model: N/A
MHRA reference: 2015/002/026/701/004
Biomerieux UK Limited: AST-P635 test kit 20 cards
02 March 2015
Device description: IVDs, bacteriology
Model: AST-P635 Test Kit 20 Cards (416911)
MHRA reference: 2015/003/003/081/023
Boston Scientific: biliary drainage catheter and biliary drainage catheter kit
March 2015
Device description: wound drains
Model: Expel drainage catheter with Twist-Loc hub
MHRA reference: 2015/003/004/131/004
ConvaTec: Niko-Fix fixation device for IV cannula with port
04 November 2015
Device description: vascular cannula/catheter accessories
Model: NF-92M
MHRA reference: 2014/010/029/701/006
Endologix: Nellix endovascular aneurysm sealing system
February 2015
Device description: implants, non active, endoprostheses for aortic aneurysms
Model: N10-100, N10-110, N10-120, N10-130, N10-140, N10-150,N10-160, N10-170, N10-180, NP-002; NP-001; NP-003; NX-00
MHRA reference: 2015/003/004/701/007
GE Healthcare Medical Systems Ltd: Engstrom Carestation, Engstrom Pro, cart only S/5EC**
Manufacturer’s reference: GEHC Ref# 34063
Device description: lung ventilators
Model: Engstrom Carestation
MHRA reference: 2015/003/004/131/003
Hamilton Medical UK
19 February 2015
Device description: ventilator
Model: Hamilton-G5/Hamilton –S1
MHRA reference: 2015/001/029/401/017
Keeler: Keeler wall-plug power supply
10 February 2015
Device description: optical, ophthalmic instruments and equipment
Part number: EP29-32777
MHRA reference: 2015/002/011/081/014
MAKO Surgical Corp: robotic arm interactive orthopedic system (RIO)
24 February 2015
Device description: surgical navigation system
Model: RIO 2.0
MHRA reference: 2015/002/009/071/005
Mast Group Ltd: Mast Manitol salt agar
Manufacturer’s reference: C5514
Device description: IVDs, bacteriology
Model: Mast manitol salt agar (DM160D)
MHRA reference: 2015/002/027/601/001
Ondal: AC2000 S/arm
02 March 2015
Device description: lamps and lights
Model: AC2000
MHRA reference: 2014/012/016/601/003
Philips Medical Systems BV: Allura Xper R7.2.x**
27 January
Device description: X-ray, fluoroscopy systems
Model: cardio/angio system
MHRA reference: 2015/003/002/081/012
Philips, Mobile X-Ray Practix Convenio
20 January 2015
Device description: X-ray, digital acquisition systems
Model: 704005
MHRA reference: 2015/003/003/081/005
Philips Medical Systems (CLE): various brands
10 November 2014
Device description: computed tomography
Models: 728130, 728231, 728235, 728240, 728243, 728244, 728246, 728251, 728256, 728306, 728311, 728317, 728321, 728323, 728326.
MHRA reference: 2014/004/028/291/007
Pulsion Medical Systems: ProAQT Sensor
26 February 2015
Device description: infusion & transfusion, administration sets
Model: PV8810 ProAQT Sensor
MHRA reference: 2015/002/027/701/002
Siemens AG Medical Solutions: syngo.plaza
15 February 2015
Device description: picture archiving and communication system (PACS)
Model: syngo.plaza
MHRA reference: 2014/010/008/601/002
Stryker Orthopaedics-Mahwah: Triathlon distal capture assembly
11 February 2015
Device description: joint prosthesis, knee
Model: Triathlon distal capture assembly
MHRA reference: 2015/002/027/081/001
Synthes: Trauma DHS/DCS impactor tip**
26 February 2015, manufacturer’s reference: R2014204R
Device description: osteosynthesis, bone screws
Model: Orthopaedic bone screw, non-bioabsorbable, sterile
MHRA reference: 2015/003/003/081/008
Synthes: Inserter f/TEN
26 February 2015, manufacturer’s reference: R2014189
Device description: surgical instruments, implant
Model: Inserter f/TEN
MHRA reference: 2015/003/003/081/012
Zimmer CAS: Zimmer PSI shoulder system
02 March 2015
Device description: joint prosthesis, shoulder
Model: Zimmer PSI shoulder system
MHRA reference: 2015/003/004/081/002