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