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
Becton Dickinson: Alaris 鈩� VP Plus with Guardrails鈩�
01 January 2019
Infusion systems
Model: 9003MED01-G, 9003TIG01-G, 9003TIG03-G
MHRA reference:
GeneOhm Sciences (Becton Dickinson): BD MAX鈩� Enteric Bacterial Panel
11 February 2019
IVDs, bacteriology
MHRA reference:
Elcon Medical Instruments: Laparoscopic handle with HF-connection (w or w/o r
14 February 2019
Surgical instruments, articulated holding
MHRA reference:
GE Healthcare: Carescape R860
GEHC ref# 34095-A
Lung ventilators
MHRA reference:
GE Medical Systems: Carescape One
GEHC ref# 36136
Monitors, patient
MHRA reference:
Maquet (Getinge): Pre-Bypass Filter
18 February 2019
Infusion & transfusion, heart lung circuits
Model: 70102.1039; 70102.1040; 70103.1084; 70103.1086
MHRA reference:
Marquardt: Staple 脴 1.0mm, 90掳
13 February 2019
Osteosynthesis, skeletal pins, wires & staples
Model: 12.91009.012S
MHRA reference:
Sequent Medical: WDC - WEB (R) Detachement Controller
14 February 2019
Implants, non-active, embolisation products Model: WDC-1
MHRA reference:
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:
Siemens Healthcare: Enzygnost Syphilis
January 2019
IVDs, bacteriology
MHRA reference:
Stanmore: Femoral Heads
18 February 2019
Joint prosthesis, hip
Model: msfmh/cc28-3.5
MHRA reference:
Tristel Solutions: TRISTEL DUO ULT
18 February 2019
Sterilization, healthcare
TSL022601
MHRA reference:
X-spine Systems (Xtent): Calix Lumbar Spinal Implant System
01 September 2018
Spinal implants
Model: Please see FSN
MHRA reference: