Field safety notices - 23 to 27 March 2015
List of field safety notices (FSNs) from medical device manufacturers from 23 to 27 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
View the latest FSNs
Axis-Shield Diagnostics: Axis-Shield liquid stable (LS) 2-part homocysteine reagent
20 March 2015
Device description: IVDs, clinical chemistry
Model: FHRW & FHBC variants
MHRA reference: 2015/003/023/601/006
Bard Peripheral Vascular: ConQuest PTA balloon dilatation catheter
FA2015-02
Device description: vascular cannula and catheters
MHRA reference: 2015/003/025/701/002
Biomet: OXF.UNI C/LESS TIB TRAY LM E
23 March 2015
Device description: joint prosthesis, knee
MHRA reference: 2015/003/023/701/022
CooperSurgical: Wallach LL100 cryosurgical system
13 March 2015
Device description: surgical, cryogenic
Models: 900019-70 900019-70 900019-70 900019-70 900019-70 900019-70 900019-70 900019-70 900019-70
MHRA reference: 2015/003/025/701/005
Covidien: Trellis™ 8 peripheral infusion system
23 March 2015
Device description: vascular cannula and catheters
Model: Trellis 8
MHRA reference: 2015/003/023/071/007
Dako: Dako Autostainer
Reference: CAPA00475
Device description: IVDs, cytopathology and histopathology
MHRA reference: 2015/003/019/181/006
Dameca: Siesta i TS
24 March 2015
Device description: anaesthetic machines & monitors
MHRA reference: 2015/003/025/131/002
Elekta: Synergy XVI
Reference: 200 01 304 054
Device description: radiotherapy
MHRA reference: 2015/003/020/701/006
Intuitive Surgical: da Vinci® Xi™ surgical system
23 March 2015
Device description: endoscopes, rigid
Model: IS4000 surgical systems (patient side cart component)
MHRA reference: 2015/003/023/701/021
Microtek Medical: da Vinci Surgical System drapes
24 March 2015
Device description: surgical drapes, gowns, masks
Model: Affected product for Tear-Away Labels: 420015-03, 420022-02, 420256-01, 420258-01, 420279-03, 420291-03, 420290-03 Affected product for Cloudy / Waxy Appearance: 400015-03, 400016-04, 400027-04, 420015-03, 420017-03, 420022-02, 420026-01, 420256-01, 420258-01, 420273-02, 420279-03, 420281-02, 420290-03, 420291-03
MHRA reference: 2015/003/025/701/006
Natus Medical: neoBLUE® blanket phototherapy LED system
Reference: CAPA001888
Device description: Therapy, infant phototherapy
Model: i. 007299 neoBLUE® blanket LED Phototherapy System with Large blanket/pad EURii. 006254 neoBLUE® blanket LED Light Boxiii. 007300 neoBLUE® blanket LED Phototherapy System with Small blanket/pad EURiv. 007296 neoBLUE® blanket LED Phototherapy System with Large blanket/pad UK
MHRA reference: 2015/003/020/701/004
Nobel Biocare
19 March 2015
Device description: implants, dental
MHRA reference: 2015/003/020/701/001
Philips Medical Systems: accessory device – uninterruptible power supply (UPS)
9 March 2015
Device description: X-ray, digital acquisition systems
Model: All systems supported by UPS devices
MHRA reference: 2015/003/025/131/001
Philips Medical Systems: Juno DRF
3 February 2015
Device description: X-ray, fluoroscopy systems
Model: 709020
MHRA reference: 2015/003/017/081/010
Radiometer Medical: AQT90 FLEX
Reference: FAN 915-336
Device description: IVDs, haematology
MHRA reference: 2015/003/020/181/002
Siemens: Mevatron, Primus, Oncor, Artiste
Reference: TH016 14 S
Device description: radiotherapy
Models: 08139789, 05863472, 05857912, 07360717, 05857920, 04504200, 01940035, 05500371, 09822685, 09411588, 09822693, 08515520, 01940753, 01924500, 09401506, 09401407, 09401316, 09401746, 09401654.
MHRA reference: 2014/012/019/601/015
Sivantos: Unity 2, Unity 3
23 February 2015
Device description: audiometers
Model: NGP 70 T+NGP 70 BK
MHRA reference: 2015/003/020/601/005
Synthes
6 March 2015
Device description: spinal implants
Model: 388.550 & 388.656
MHRA reference: 2015/003/025/701/001
Uresil: Thoracic vent procedure tray
25 February 2015
Device description: surgical devices, non-powered
MHRA reference: 2015/002/009/081/012
Zimmer: Anatomical Shoulder™ handle for rasp
20 March 2015
Device description: surgical instruments, implant
MHRA reference: 2015/003/023/701/013