Field Safety Notices: 11 to 16 July 2021
Summary list of field safety notices (FSNs) from medical device manufacturers from 11 to 16 July 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
View a
View . FSNs before this date are on the
Abbott: Alinity s System
12 July 2021
IVDs, clinical chemistry
MHRA reference:
Beckman Coulter: Kaluza C Flow Cytometry Software
02 July 2021
IVDs, haematology
MHRA reference:
Becton Dickinson: Groshong Catheters()
01 July 2021
Vascular cannula and catheters
MHRA reference:
Boston Scientific: EMBLEM S-ICD Subcutaneous Electrode (Lead)
15 July 2021
Implants, active, cardiac subcutaneous system
Model: 3501
MHRA reference:
CareDx: Olerup QTYPE 11
08 July 2021
IVDs, immunology
MHRA reference:
GE Healthcare: Patient Data Module
30 June 2021
Monitors, patient
MHRA reference:
Illumina: VeriSeq NIPT Solution v2
04 July 2021
IVD, genetic testing
MHRA reference:
Medtronic: Vectris SureScan MRI Lead kit
July 2021
Implants, active, leads, neuro
Model: 977A260, 977A275, 977A290
MHRA reference:
Merit Medical: BasixALPHA
24 June 2021
Surgical instruments, minimal access
MHRA reference:
Philips Health Systems: V60 Ventilator
V60 Plus Ventilator
July 2021
Lung ventilators
MHRA reference:
Stryker: Restoris MCK Femoral Trial
13 July 2021
Joint prosthesis, knee
MHRA reference:
Tornier: Aequalis Pyrocarbon Humeral Head
05 July 2021
Joint prosthesis, shoulder
Model: All sizes
MHRA reference:
TyTek Medical: TPAK & TPAK10
09 June 2021
Surgical instruments, minimal access
Model: TM 303 & TM 310
MHRA reference:
Vapotherm: Oxygen Assist Module (OAM)
09 February 2021
Humidifiers
MHRA reference: