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聽FSN聽contact the manufacturer.
Latest FSNs
You can see copies of field safety notices in our .
Abbott: ARCHITECT Anti-HBc II
24 February 2015
Device description: IVDs, clinical chemistry
Model: N/A
MHRA reference:
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:
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:
ConvaTec: Niko-Fix fixation device for IV cannula with port
04 November 2015
Device description: vascular cannula/catheter accessories
Model: NF-92M
MHRA reference:
Endologix: Nellix endovascular aneurysm sealing system
February 2015
Device description: implants, non active, endoprostheses for aortic aneurysms
Model: N10-100, N10-110, N10-120, 聽N10-130, N10-140, N10-150,N10-160, N10-170, N10-180, NP-002; NP-001; NP-003; NX-00
MHRA reference:
GE Healthcare Medical Systems Ltd: Engstrom Carestation, Engstrom Pro, cart only S/5EC**
Manufacturer鈥檚 reference: GEHC Ref# 34063
Device description: lung ventilators
Model: Engstrom Carestation
MHRA reference:
Hamilton Medical UK
19 February 2015
Device description: ventilator
Model: Hamilton-G5/Hamilton 鈥揝1
MHRA reference:
Keeler: Keeler wall-plug power supply
10 February 2015
Device description: optical, ophthalmic instruments and equipment
Part number: EP29-32777
MHRA reference:
MAKO Surgical Corp: robotic arm interactive orthopedic system (RIO)
24 February 2015
Device description: surgical navigation system
Model: RIO 2.0
MHRA reference:
Mast Group Ltd: Mast Manitol salt agar
Manufacturer鈥檚 reference: C5514聽 聽 聽 聽
Device description: IVDs, bacteriology
Model: Mast manitol salt agar (DM160D)
MHRA reference:
Ondal: AC2000 S/arm
02 March 2015
Device description: lamps and lights
Model: AC2000
MHRA reference:
Philips Medical Systems BV: Allura Xper R7.2.x**
27 January
Device description: X-ray, fluoroscopy systems
Model: cardio/angio system
MHRA reference:
Philips, Mobile X-Ray Practix Convenio
20 January 2015
Device description: X-ray, digital acquisition systems
Model: 704005
MHRA reference:
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:
Pulsion Medical Systems: ProAQT Sensor
26 February 2015
Device description: infusion & transfusion, administration sets
Model: PV8810 ProAQT Sensor
MHRA reference:
Siemens AG Medical Solutions: syngo.plaza
15 February 2015
Device description: picture archiving and communication system (PACS)
Model: syngo.plaza
MHRA reference:
Stryker Orthopaedics-Mahwah: Triathlon distal capture assembly
11 February 2015
Device description: joint prosthesis, knee
Model: Triathlon distal capture assembly
MHRA reference:
Synthes: Trauma DHS/DCS impactor tip**
26 February 2015, manufacturer鈥檚 reference: R2014204R
Device description: osteosynthesis, bone screws
Model: Orthopaedic bone screw, non-bioabsorbable, sterile
MHRA reference:
Synthes: Inserter f/TEN
26 February 2015, manufacturer鈥檚 reference: R2014189
Device description: surgical instruments, implant
Model: Inserter f/TEN
MHRA reference:
Zimmer CAS: Zimmer PSI shoulder system
02 March 2015
Device description: joint prosthesis, shoulder
Model: Zimmer PSI shoulder system
MHRA reference: