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

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