Field Safety Notices: 8 to 12 March 2021
List of field safety notices (FSNs) from medical device manufacturers from 8 to 12 March 2021
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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Accuray: CyberKnife Treatment Delivery System
26 February 2021
Radiotherapy
Model: CyberKnife treatment delivery system
MHRA reference:
B Braun: Univation X System
04 March 2021
Joint prosthesis, knee
Model: NO156K, NO157K, NO158K, NO159K, NO160K, NO161K, NO162K, NO163K, NO164K, NO165K, NO166K, NO167K, NO168K, NO169K, NO170K, NO171K, NO172K, NO173K, NO174K, NO175K, NO176K, NO177K, NO178K, NO179K, NO180K, NO181K, NO182K, NO183K, NO184K, NO185K, NO186K, NO187K, NO188K, NO189K, NO190K, NO191K, NO192K, NO193K, NO194K, NO195K, NO196K, NO197K, NO198K, NO199K, NO156Z, NO157Z, NO158Z, NO159Z, NO160Z, NO161Z, NO162Z, NO163Z, NO164Z, NO165Z, NO166Z, NO167Z, NO168Z, NO169Z, NO170Z, NO171Z, NO172Z, NO173Z, NO174Z, NO175Z, NO176Z, NO177Z, NO178Z, NO179Z, NO180Z, NO181Z, NO182Z, NO183Z, NO184Z, NO185Z, NO186Z, NO187Z, NO188Z, NO189Z, NO190Z, NO191Z, NO192Z, NO193Z, NO194Z, NO195Z, NO196Z, NO197Z, NO198Z, NO199Z, NO156K, NO157K, NO158K, NO159K, NO160K, NO161K, NO162K, NO163K, NO164K, NO165K, NO166K, NO167K, NO168K, NO169K, NO170K, NO171K, NO172K, NO173K, NO174K, NO175K, NO176K, NO177K, NO178K, NO179K, NO180K, NO181K, NO182K, NO183K, NO184K, NO185K, NO186K, NO187K, NO188K, NO189K, NO190K, NO191K, NO192K, NO193K, NO194K, NO195K, NO196K, NO197K, NO198K, NO199K, NO156Z, NO157Z, NO158Z, NO159Z, NO160Z, NO161Z, NO162Z, NO163Z, NO164Z, NO165Z, NO166Z, NO167Z, NO168Z, NO169Z, NO170Z, NO171Z, NO172Z, NO173Z, NO174Z, NO175Z, NO176Z, NO177Z
MHRA reference:
B.Braun: HISTOACRYL BLUE / LAPFIX / PROSET OFX
08 March 2021
Adhesive control devices
Model: 1050044, 1050052
MHRA reference:
This original Field Safety Notice (FSN) has been updated by FSNs dated and which include different models and batch numbers.
Please note the FSN dated 15 March originally contained a typographical error referring to an FSN of 3 March. This has been amended by the manufacturer and now correctly refers to the FSN dated 8th March.
Baxter: COLLEAGUE SINGLE CHANNEL CXE, COLLEAGUE SINGLE CHANNEL MONO, COLLEAGUE TRIPLE CHANNEL CXE, COLLEAGUE TRIPLE CHANNEL MONO
15 March 2021
Infusion systems
Model: 2M91617, 2M81517, 2M81517K, 2M91637, 2M81537K
MHRA reference:
BD: Infusion Sets for Alaris Pumps and Gravity Infusion sets and connectors
10 March 2021
Infusion & transfusion, administration sets
Model: GP, VP, CC, GW/GW800 and SE, IVAC 590 series, Gravity
MHRA reference:
Biotronik: ICD and CRT-D devices
March 2021
Implants, active, defibrillators
Model: Idova, Iforia, Ilesto/Inventra, Iperia, Itrevia/Ilivia, Inlexa, Intica/Ilivia Neo, Intica Neo ICDs and CRT-Ds
MHRA reference:
COOK Medical: Bander Ureteral Diversion Stent Set
08 March 2021
Implants, non active, non vascular stents
Model: 025227
MHRA reference:
EBR Systems: WiSE CRT Transmitter
03 March 2021
Implants, active, intracardiac (leadless)
Model: 4100
MHRA reference:
Ferring Pharmaceuticals:ZomaJet Injector Device for Zomacton (somatropin)
05 March 2021
Injection devices
Model: ZomaJet 10, ZomaJet 2 Vision, ZomaJet Vision X
MHRA reference:
LumiraDx: SARS-CoV-2 Ag Test Strip Kit
02 March 2021
IVDs, SARS-CoV-2 Instrumentation antigen test
Model:L016000101048, 5000275 (GM2000220), 5000243 (GM2000195), 5000263 (GM2000212), 5000265 (GM2000218)
MHRA reference:
Medline: OPS Essential Gowns
01 March 2021
Surgical drapes, gowns, masks
Model: S3510P-19MAE507, S3540P-19MAE507, S3500P-19MAE498
MHRA reference:
Medtronic:Bravo System
March 2021
Implants, active, monitors and recorders
Model: FGS-0312, FGS-0313, FGS-0635, FGS-0636
MHRA reference:
Natus: RetCam Envision
03 March 2021
Optometry equipment
Model: RetCam Envision Lens (60-000090)
MHRA reference:
Roche Diagnostics: Elecsys CA 19-9
February 2021
IVDs, Clinical Chemistry
Model: 07027028 190
MHRA reference:
WEINMANN Medical Technology: MEDUMAT Transport
February 2021
Lung ventilators
Model: WM 28300 and WM 28400
MHRA reference: