Field Safety Notice - 5 to 9 June 2017
Summary List of field safety notices (FSNs) from medical device manufacturers from 5 to 9 June 2017
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
Abbott: HeartMate 3 LVAS Implant Kit, HeartMate 3 Pump
7 June 2017
Implantable ventricular assist devices
Model: 106524/ 106524INT ,10001696/ 10001696INT
MHRA reference:
Alcon: LuxOR / LX3 Microscope Floor Stand
1 June 2017
Surgical equipment, miscellaneous
MHRA reference:
ArjoHuntleigh: Flowtron ACS900
FSN/SUZ/001-2017
Therapy, miscellaneous
Model: 526000-03, 526000-04, 526000-07, 526000-08, 526000-09, 526000-10
MHRA reference:
Atrium Medical: Atrium Advanta V12 Balloon Expandable Covered Stent
June 2017
Implants, non active, endoprostheses for aortic aneurysms
MHRA reference:
Balt Extrusion: LEO+
5 April 2017
Implants, non active, embolisation products
Model: LEO3.5x25
MHRA reference:
Biomet: Comprehensive Nano Humeral Component PPS
6 June 2017
Joint prosthesis, shoulder
MHRA reference:
Beckman Coulter: DxH 500
2 June 2017
IVDs, haematology
MHRA reference:
Bentley InnoMed: BeGraft Peripheral Plus Stent Graft System
31 May 2017
Implants, non active, peripheral vascular stents
MHRA reference:
bioM茅rieux: VITEK 2
25 May 2017
IVDs, bacteriology
MHRA reference:
Draeger: Terminal units and probes
May 2017
Anaesthetic & breathing, medical gas pipelines
MHRA reference:
Intersurgical: Manual Resuscitation Systems
5 June 2017
Resuscitators
MHRA reference:
Medela: AXS Universal Aspiration Tubing
30 May 2017
Suction equipment
MHRA reference:
Melius Pro B.V.: Simple Up CL (cordless)
June 2017
Trolleys and chairs
Model: SU-1350-CL
MHRA reference:
Newdeal: METIS庐 - Metatarsal trial implant size 1
23 May 2017
Orthopaedic surgical instruments - measuring tools
MHRA reference:
Ohmeda Medical: Ohio Infant Warmer Systems
FMI 32047-2
Infant, warmers
Model: New identified models: 3051 Iws, 3400 IWS
MHRA reference:
Philips: DuraDiagnost
18 May 2017
X Ray, digital acquisition systems
MHRA reference:
Randox Laboratories: HbA1c
6 June 2017
IVDs, clinical chemistry
Model: HA3830
MHRA reference:
ResMed: Astral 100, Astral 100SC, Astral 150
8 June 2017
Lung ventilators
Model: 100, 100SC, 150
MHRA reference:
STEPHANIX: D2RS
RC17002
Imaging, patient support
MHRA reference:
Toshiba: Diagnostic Ultrasound System
5 June 2017
Ultrasound, imaging
Model: US-X100, TUS-X200, TUS-A300, TUS-A400, TUS-A500 TUS-AI700, TUS-AI800, TUS-AI900 TUW-U001, TUW-U001S
MHRA reference:
Unisurge: Unisurge International Limited Supasnip Scissors
25 May 2017
Surgical instruments, articulated cutting
Model: F811004
MHRA reference:
Vascular Solutions: Venture RX Catheter, Venture OTW Catheter, and Venture CS Catheter
25 April 2017
Vascular cannula and catheters
Model: 5820, 5821, 5822
MHRA reference:
Zimmer Biomet: Various Trauma & Extremity Instruments (Drill bits and Screw taps)
7 June 2017
Orthopaedic surgical instruments - cutting tools
MHRA reference:
Zimmer: Trauma Implants
31 May 2017
Osteosynthesis, bone plates
Model: Trauma Implants
MHRA reference: