Field Safety Notice: 18 to 22 February 2019
List of field safety notices (FSNs) from medical device manufacturers from 18-22 February 2019
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
Becton Dickinson: Alaris ™ VP Plus with Guardrails™
01 January 2019
Infusion systems
Model: 9003MED01-G, 9003TIG01-G, 9003TIG03-G
MHRA reference: 2019/002/018/487/009
GeneOhm Sciences (Becton Dickinson): BD MAX™ Enteric Bacterial Panel
11 February 2019
IVDs, bacteriology
MHRA reference: 2019/002/014/228/008
Elcon Medical Instruments: Laparoscopic handle with HF-connection (w or w/o r
14 February 2019
Surgical instruments, articulated holding
MHRA reference: 2019/002/019/487/010
GE Healthcare: Carescape R860
GEHC ref# 34095-A
Lung ventilators
MHRA reference: 2019/002/015/701/018
GE Medical Systems: Carescape One
GEHC ref# 36136
Monitors, patient
MHRA reference: 2019/002/019/701/016
Maquet (Getinge): Pre-Bypass Filter
18 February 2019
Infusion & transfusion, heart lung circuits
Model: 70102.1039; 70102.1040; 70103.1084; 70103.1086
MHRA reference: 2019/002/019/487/029
Marquardt: Staple Ø 1.0mm, 90°
13 February 2019
Osteosynthesis, skeletal pins, wires & staples
Model: 12.91009.012S
MHRA reference: 2019/002/019/487/012
Sequent Medical: WDC - WEB (R) Detachement Controller
14 February 2019
Implants, non-active, embolisation products Model: WDC-1
MHRA reference: 2019/002/019/487/024
Siemens Healthcare: UROSKOP OMNIA and UROSKOP OMNIA MAX
UI XP004/19/S (FSN) and XP006/19/S (FSCA)
X Ray, fluoroscopy systems
Model: 10094910 and 10762473
MHRA reference: 2019/002/013/601/005
Siemens Healthcare: Enzygnost Syphilis
January 2019
IVDs, bacteriology
MHRA reference: 2019/002/018/487/006
Stanmore: Femoral Heads
18 February 2019
Joint prosthesis, hip
Model: msfmh/cc28-3.5
MHRA reference: 2019/002/019/487/019
Tristel Solutions: TRISTEL DUO ULT
18 February 2019
Sterilization, healthcare
TSL022601
MHRA reference: 2019/002/019/601/001
X-spine Systems (Xtent): Calix Lumbar Spinal Implant System
01 September 2018
Spinal implants
Model: Please see FSN
MHRA reference: 2019/001/031/701/002
Last updated 26 February 2019 + show all updates
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Added correct link for the Stanmore: Femoral Heads FSN
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First published.