Field Safety Notice: 13 to 17 January 2020
List of field safety notices (FSNs) from medical device manufacturers from 13 January to 17 January 2020
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
BAAT Medical Products B.V: AVON Anterior Resection Plate
NCR_0344 / Stryker ref RA2019- 2254435
Osteosynthesis, bone plates
Model: 0901601002
MHRA reference: 2020/001/013/291/002
Bard Access Systems: BARD Site~Rite 8 Ultrasound System
09 January 2019
Ultrasound, imaging
MHRA reference: 2020/001/007/228/004
BIOMERIEUX: NUCLISENS® Lysis Buffer
17 January 2020
IVDs, viral microbiology
MHRA reference: 2020/001/016/487/010
Cardinal Health (Cordis): Cordis® POWERFLEX® P3 PTA Dilatation Catheter
09 January 2020
Vascular cannula and catheters
MHRA reference: 2020/001/010/291/003
GE Healthcare: 1.5T SIGNA HDxt SIGNAWorks Edition (2019 upgrade for 1.5T SIGNA HDxt systems) - HD28 SIGNA Architect - DV26 (China only) SIGNA Architect - DV28 SIGNA Pioneer - PX28 SIGNA Premier - RX28
FMI 60961
Magnetic resonance, equipment & accessories
MHRA reference: 2020/001/010/291/001
GB (UK) Healthcare (Enteral): Enteral-ISOSAF 1ml Low Dose ENFit Single Use Syringe
14 January 2020
Feeding systems and tubes
MHRA reference: 2020/001/014/487/010
Getinge Disinfection AB: 17 January 2020
CAPA 219071
Cssd wash/clean/drying equipment
Model: 88-5
MHRA reference: 2020/001/014/291/002
Mathys: Affinis Inverse glenosphere 39
14 January 2020
Joint prosthesis, shoulder
Model: 60.30.3039
MHRA reference: 2020/001/015/291/012
Medline Industries: Charger, EU plug
10 January 2020
Surgical equipment, miscellaneous
MHRA reference: 2020/001/014/291/001
Olympus: OLYMPUS EVIS LUCERA PLEURAVIDEOSCOPE
January 2020
Endoscopes, Rrgid
MHRA reference: 2020/001/015/291/001
Radiometer Medical ApS: ABL90 FLEX/FLEX PLUS analyzers
FAN 915-404
IVDs, extra laboratory testing
Model: 393-090/393-092
MHRA reference: 2020/001/016/487/019
Siemens: Ysio Max, Luminos dRF Max, Agile Max, Omnia Max
January 2020
X ray, general
Model: 10762470, 10762471, 10762472, 10762473
MHRA reference: 2020/001/009/601/006
Siemens Healthcare Diagnostics: Atellica IM 1300 and IM 1600 Analyzers
January 2020
IVDs, clinical chemistry
MHRA reference: 2020/001/008/601/004
Siemens Healthcare Diagnostics Inc: Enzymatic Creatinine Rgt
December 2019
IVDs, clinical chemistry
Model: Atellica:11097533, ADVIA: 10335869, Dimension 10471520, Dimension Vista XXXX
MHRA reference: 2020/001/008/601/003
Siemens Healthcare Diagnostics Inc: ADVIA Chemistry Lipase
December 2019
IVDs, clinical chemistry
MHRA reference: 2019/012/031/601/001
Sterisets International: Syringe NaCi 0.9% Luer Lock 20 ml
08 July 2019
Vascular cannula/catheter accessories
Model: Product Ref 14364S
MHRA reference: 2020/001/013/291/001
Teleflex: Rusch Greenlite (MAC 3)
13 January 2020
Airway devices
MHRA reference: 2020/001/014/487/006
Vectura Group: Breelib
September 2018
Nebulizers
Model: 08CD1042, 08CD1050, 08CD1051, 08CD1046
MHRA reference: 2020/001/015/601/001
William Cook: Zenith Alpha Abdominal Endovascular Graft
14 January 2020
Implants, non active, endoprostheses for aortic aneurysms
MHRA reference: 2020/001/015/291/007