Field Safety Notices - 29 August - 2 September 2016
Summary List of field safety notices (FSNs) from medical device manufacturers from 29 August - 2 September 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.
Latest FSNs
Biomet: Left MD Tibial Jig Tail Optilock
31 August 2016
Osteosynthesis, bone plates
MHRA reference: 2016/008/031/701/013
Cascade Designs: Cascade Designs Inc. / Varlite
19 August 2016
Pressure relief cushions
MHRA reference: 2016/009/001/291/018
Covidien / Medtronic: Puritan Bennett 980 ventilator
4 August 2016
Lung ventilators
MHRA reference: 2016/002/001/701/018
Hamilton Bonaduz AG: HAMILTON-MR1 ventilators
18 August 2016
Lung ventilators
MHRA reference: 2016/008/016/299/023
Human Care: Human Care Roomer S and Altair overhead lift
8 July 2016
Hoists and slings Model: Human Care Roomer S and Altair 55200-EU/AU/GB/NA/JP, 55210- EU/AU/GB/NA/JP, 55220- EU/AU/GB/NA/JP, 55300- EU/AU/GB/NA/JP
Human Care Roomer S and Altair
MHRA reference: 2016/008/030/291/018
Implant Direct Sybron Manufacturing: InterActive® Implant Open-Tray Transfer Narrow
19 May 2016
Implants, dental
Model: 6534-08N
MHRA reference: 2016/008/031/601/001
Kymco: Mini Comfort
25 July 2016
Scooters, powered
Model: Mini Comfort EQ20CG
MHRA reference: 2016/008/011/601/002
Maquet: Maquet Heater and Maquet heater/cooler systems
22 August 2016
Blood/fluid warming systems
Model: HU35, HCU20, HCU30, HCU40
MHRA reference: 2016/008/025/291/011
Novarad Corporation: NovaPACS
12 August 2016
Picture archiving and communication
MHRA reference: 2016/008/030/601/004
Otto Bock HealthCare: ProCarve
24 August 2016
Prostheses
Model: 3R2 ProCarve Knee Joint, 1E2 ProCarve Foot Standard, 1E2=1
MHRA reference: 2016/008/025/291/001
Sequent Medical: VIA 27 microcatheter
25 August 2016
Vascular cannula and catheters Model: FG27154-01
MHRA reference: 2016/008/025/291/022
Siemens: IMMULITE/IMMULITE 1000 and IMMULITE 2000/2000 XPi CMV (IgM)
August 2016
IVDs, clinical chemistry Model: LKCM1 (SMN# 10381296), LKCM1 (D)(SMN# 10370301), L2KCM2 (SMN# 10381320), L2KCM2 (D) (SMN# 10370302) MHRA reference: 2016/008/031/601/002
Spacelabs Healthcare: Xhibit Telemetry Receiver & Xhibit Central Station
25 August 2016
Monitors, patient
Model: Xhibit Telemetry Receiver & Xhibit Central Station 96280 & 96102
MHRA reference: 2016/009/001/291/004
Sorin: Perceval sutureless aortic heart valve
26 August 2016
Implants, non-active, cardiovascular Model: PVS21, PVS23, PVS25, PVS27
MHRA reference: 2016/008/030/291/005
Stryker: Scorpio Patella assembly instrument
RA2016-098
Orthopaedic surgical instruments - Insertion/extraction tools
Model: 3182-1000
MHRA reference: 2016/008/010/701/014
Topcon: PASCAL Synthesis (532/577) & Twinstar (577/638)
5 July 2016
Therapy, lasers Model: Synthesis
MHRA reference: 2016/008/030/291/037