Field safety notices - 7 March to 11 March 2016

List of field safety notices (FSNs) from medical device manufacturers from 7 March to 11 March 2016.


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

Abrasive Technology: Prodia

8 January 2016

Surgical power tools

MHRA reference: 2016/003/009/292/013

AB SCIEX Pte: 3200MD series and 4500MD series

4 March 2016

IVDs, clinical chemistry

Model: API 3200MD™ LC/MS/MS System, 3200MD QTRAP® LC/MS/MS System, Triple Quad™ 4500MD LC/MS/MS System, QTRAP® 4500MD LC/MS/MS System

MHRA reference: 2016/003/010/292/032

Arjo: Akron Deluxe Tilt Table

18 January 2016

Trolleys and chairs

Model: 8652XXXX, 8652TXXXX

MHRA reference: 2015/012/016/701/002

ArthroCare Corporation: TOPAZ Microdebrider

4 March 2016

Surgical, diathermy

MHRA reference: 2016/003/007/291/002

Bayer Healthcare: Essure

29 February 2016

Implants, non-active, contraceptive implants

Model: Essure 305

MHRA reference : 2016/003/007/292/022

Dexcom: G4 PLATINUM and GS Mobile receiver

February 2016

Continuous Glucose Monitoring Systems (CGMS)

Model: MT20649-1, MT20649-2, MT22719-1, MT22719-2

MHRA reference: 2016/002/025/291/005

Direct Flow Medical: DFM Transcatheter Aortic Valve System

22 July 2015

Implants, non-active, cardiovascular heart valves

MHRA reference: 2015/007/029/291/007

GE Medical Systems


Anaesthetic machines & monitors

Model: Aisys CS2

MHRA reference: 2016/003/010/292/031

GE Medical: Lightspeed 16, Discovery ST PET-CT Imaging System, LightSpeed Ultra, Discovery LS PET-CT Imaging System, and LightSpeed Pro 16


Computed tomography system

MHRA reference: 2016/003/008/291/003

Integra: Monopolar Instruments & Bipolar Instrument Handle

4 March 2016

Surgical, diathermy

Model: CEV649B5

MHRA reference: 2016/003/008/291/001

Intuitive Surgical: da Vinci Si/Xi Surgical Systems

4 March 2016

Endoscopes, rigid

Model: 380610 / SS3000, 380677 / SS4000, 380652 / PS4000

MHRA reference: 2016/003/007/701/002

KeyMed: Olympus Suction Pump

15 February 2016

Suction equipment

Model: KV-5 Olympus Suction Pump

MHRA reference: 2016/002/026/701/002

Lifetech Scientific: CeraFlex™ Atrial Septal Defect (ASD) Occluder

3 March 2016

Implants, non active, cardiac appendage and septal defect occluders / plugs

Model: L T-ASDf-OS/08/.. /30/32

MHRA reference: 2016/003/004/292/003

Lumenis: Lumenis VersaCut Morcellator

30 July 2015

Surgical instruments, non-articulated cutting

Model: GA-0007500 (VersaCut + System with Inverted H/P) and GA-0007600 (VersaCut + System with Regular H/P), which includes all products since initial product release

MHRA reference: 2016/003/009/291/001

MAKO Surgical: RESTORIS MCK Tibial Baseplate

25 February 2016

Joint prosthesis, knee

MHRA reference: 2016/002/022/292/001

Orion Pharma: QuikRead go wrCRP, QuikRead go wrCRP+H

3 March 2016

IVDs, clinical chemistry

MHRA reference: 2016/003/001/292/018

Peter Brehm: 60900-66-2 Guiding Rod


Surgical instruments, implant

MHRA reference: 2016/003/010/121/001

Siemens Healthcare Diagnostics:Triglycerides_2, Concentrated

March 2016

IVDs, clinical chemistry

Model: Triglycerides_2, Concentrated

MHRA reference: 2016/003/008/601/002

Terumo Corporation: Terumo®ACCUFORCE® PTCA Dilatation Catheter- φ2.5mm

FSCA 1508

Vascular cannula and catheters

Model: DC-RM2512HHW, DC-RM2515HHW, DC-RM2520HHW

MHRA reference: 2016/003/007/701/005

WaveLight:VERION™ Reference Unit

8 March 2016

Optical, ophthalmic instruments & equipment

MHRA reference: 2016/003/008/292/010

Zimmer: Virage OCT Spinal Fixation System

8 March 2016

Spinal Implants

MHRA reference: 2016/003/008/292/005

Zimmer Biomet: RHK Tibial Bearing

4 March 2016

Joint prosthesis, knee

MHRA reference: 2016/003/008/292/011

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