Field safety notices - 11 to 15 January 2016
List of field safety notices (FSNs) from medical device manufacturers from 11 January to 15 January 2016.
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. See more information on what an FSN is and why it’s important.
Latest FSNs
bioMérieux: API ® ZYM Bx2
January 2016
IVDs, bacteriology
MHRA reference: 2016/001/007/181/001
BrainLAB: brain metastases, adaptive hybrid surgery analysis
15 December 2015
Radiotherapy planning and verification systems
MHRA reference: 2016/001/008/292/011
Cook Medical: central venous catheters
6 January 2016
Vascular cannula and catheters
MHRA reference: 2016/001/012/292/015
CVRx: Barostim Neo
6 January 2016
Therapy, electrotherapy
Model: Barostim Neo 2102 & 9010
MHRA reference: 2016/001/007/601/017
DePuy Orthopaedics Worldwide - Ireland: SIGMA® High Performance (HP) MBT Non-Keel Punch Knee Instrument
January 2016
Surgical instruments, implant
MHRA reference: 2015/012/023/291/001
Draeger: Oxylog 3000, Oxylog 3000 plus and Oxylog 2000 plus
November 2015
Lung ventilators
MHRA reference: 2015/012/021/291/007
Ellipse A/S: Ellipse Nordlys, 9SYS7751 w/HRL 600 Applicator/handpiece
5 November 2015
Therapy, lasers
MHRA reference: 2015/012/022/291/013
Fresenius Medical Care AG: Enteral Nutrition ENfit Giving Set
6 January 2016
Feeding systems and tubes
MHRA reference: 2016/001/008/292/013
Philips Healthcare Inc: IntelliVue patient monitor
December 2015
Monitors, patient
Model: M3001A IntelliVue Measurement Module X1
MHRA reference: 2016/001/014/292/023
H-p-cosmos: h/p/cosmos treadmill
10 December 2015
Diagnostic measurement and monitoring
MHRA reference: 2016/001/005/292/019
Infomed: HF440
26 August 2015
Dialysis, haemofilters
Model: HF440
MHRA reference: 2015/009/017/081/005
Mavig: monitor suspension system GD60
11 January 2016
X-ray, fluoroscopy systems
Model: GD60-4-GE
MHRA reference: 2016/001/012/292/004
Smith & Nephew: BEAVER 4.0mm Banana Blade
14 January 2016
Surgical instruments, non-articulated cutting
MHRA reference: 2016/001/014/292/025
TRUMPF Medizin Systeme: TruLight 3000, TruLight 5000, iLED 3, iLED 5, TruV
January 2016
Lamps and lights
Model: TruLight 3000, TruLight 5000, iLED 3, iLED 5, TruV 4028110
MHRA reference: 2016/001/008/292/010
Zimmer: NexGen PRI femoral impactor head
22 May 2015
Joint prosthesis, hip
MHRA reference: 2015/005/028/071/001