Field Safety Notices: 30 November to 4 December 2020
List of field safety notices (FSNs) from medical device manufacturers from 30 November to 4 December 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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Aidence: Veye Chest
November 2020
Picture archiving and communication system (PACS)
Model: 2
MHRA reference:
Boston Scientific: Hot AXIOS鈩� (See FSN)
01 December 2020
Implants, non active, non vascular stents
Model: See FSN
MHRA reference:
Boston Scientific: EMBLEM鈩� S-ICD and EMBLEM鈩� MRI S-ICD
December 2020
Implants, active, cardiac subcutaneous system
Model: Model A209 - A219
MHRA reference:
Implantcast: IFU/ ST: EcoFit庐 cup / EcoFit庐 cup EPORE庐
30 November 2020
Joint Prosthesis, Hip
Model: Ecocuope, ecoepope 09300038, 38000025, 38000030, 38000035, 38000040, 38000530, 38000535, 38000540.
MHRA reference:
Medtronic: TA鈩� Auto SutureTM Vascular Stapler with DST SeriesTM Technology 30mm -V3
November 2020
Staples and staple guns
Model: TA30V3L, TA30V3S
MHRA reference:
Merit Medical: Prelude SNAP鈩�; Worley鈩�
1721504-08/31/20-005R
Vascular cannula and catheters
MHRA reference:
Philips Medical Systems: JETStream庐 Workspace
November 2020
PET-CT
Model: 882310, 882311, 882313
MHRA reference:
Roche Diagnostics: Cobas 8000 Core Unit, model number: 05641446001
cobas pro sample supply unit, model number: 08464502001 cobas c 513 analyzer commercial system, model number: 07649142001
November 2020
IVDs, clinical chemistry
model number: 05641446001, 08464502001 & 07649142001
MHRA reference:
Siemens: ADVIA and Atellica GGT reagent
November 2020
IVDs, clinical chemistry Model: ADVIA SMN 10309495,10316298 Atellica SMN 11097597
MHRA reference:
Siemens Healthcare: Artis zee/Q/Q.zen
November 2020
X Ray, Fluoroscopy Systems
Model: Artis zee/Q/Q.zen sytems with siemens healthineers table (Tilt/Step, OR) and with software version VD11E
MHRA reference:
Silony Medical: Roccia Hooked Implant Driver ; RI-1342
13 November 2020
Orthopaedic surgical instruments - insertion/extraction tools
MHRA reference:
Stryker: Stryker SmartLife Large Aseptic Housings
April 2021
Surgical power tools
Model: 7126-120-000
MHRA reference:
The Binding Site: Optilite Freelite kappa free kits
30 November 2020
IVDs, clinical chemistry
Model: LK016.OPT, LK016.10.OPT, LK016.M.OPT
MHRA reference:
Wallac (PerkinElmer): Vanadis Core Buffer kit
27 November 2020
IVDs, viral microbiology
Model: Instrumentation/ platform 3223-0010
MHRA reference: