Field Safety Notice: 24 to 28 June 2019
List of field safety notices (FSNs) from medical device manufacturers from 24 to 28 June 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: BD Microtainer® K2E Tubes
PAS-19-1526
IVDs, specimen receptacles
MHRA reference: 2019/006/004/291/001
Biomet: Comprehensive Reverse Shoulder Inst Outer Case
24 June 2019
Surgical devices, non-powered
MHRA reference: 2019/006/024/487/015
Critical Diagnostics: Presage ST2 Assay
FSCA 19-002
IVDs, clinical chemistry
Model: BC-1065E
MHRA reference: 2019/006/024/228/004
Drive Devilbiss: SAMSOFT 175 - MINI SAMSOFT 150 - SAMSOFT+ - MINI SAMSOFT+
15 January 2019
Hoists and slings
MHRA reference: 2019/005/015/601/006
Elekta Ltd: HexaPOD evo RT System
June 2019
Radiotherapy
Model: P10603-109, P10603-110 and P10603-111
MHRA reference: 2019/006/024/701/019
Elitech Group: STI PLUS ELITe MGB Kit
19 June 2019
IVDs, bacteriology
MHRA reference: 2019/006/020/701/011
Fast Track Diagnostics: FTD ACE
June 2019
IVDs, clinical chemistry
MHRA reference: 2019/006/024/487/016
Fast Track Diagnostics FSN-FA-2019-05: FTD Neuro 9
June 2019
IVDs, viral microbiology
MHRA reference: 2019/006/025/487/001
GBUK Group (Enteral): Nutricare Infant Feeding Tube
26 June 2019
Feeding systems and tube
Model: NCI06.050ISOSAF-ROW
MHRA reference: 2019/006/026/601/005
GE Healthcare: ECG trunk cables, ECG Leadwires
39001-ROW
ECG
MHRA reference: 2019/006/027/701/006
Immundiagnostik AG
13 June 2019
IVDs, clinical chemistry
MHRA reference: 2019/006/021/487/004
KeyMed (Olympus): Nurses Control Panel Arm - Long
21 June 2019
Endoscopes, televisual systems
Model: Nurses Control Panel Arm - Long - MAJ-1664
MHRA reference: 2019/006/021/701/007
NuVasive: MAGEC Spinal Bracing and Distraction System
25 June 2019
Spinal implants
MHRA reference: 2019/006/027/487/006
Roche: MYO2 (Tina-quant Myoglobin Gen.2)
June 2019
IVDs, clinical chemistry
MHRA reference: 2019/006/020/701/008
Teleflex: Various
25 June 2019
Vascular cannula and catheters
MHRA reference: 2019/006/025/701/027