Field Safety Notices: 28 June to 2 July 2021
Summary list of field safety notices (FSNs) from medical device manufacturers from 28 June to 2 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 list of FSNs published since January 2020
View FSNs since November 2014. FSNs before this date are on the National Archives website
ArjoHuntleigh: IndiGo Intuitive Drive Assistance
26 May 2021
Bed and accessories
Model: INDI-XXX
MHRA reference: 2021/005/019/601/501
bioMérieux: ETEST IMIPENEM RELEBACTAM-WW & US
01 July 2021
IVDs, bacteriology
Model: ETEST
MHRA reference: 2021/006/029/291/009
Cantel: nnova E-Series Endoscope Reprocessor
31 May 2021
Cssd wash/lecan/drying equipment
Model: Innova E3s, Innova E3s CMS, Innova E4s CMS
MHRA reference: 2021/006/028/000/001
Ethicon: INTERCEED Absorbable Adhesion Barrier
GYNECARE INTERCEED Clinical Study Results Wound management
MHRA reference: 2021/006/025/487/009
Leica Biosystems Newcastle: BOND-MAX & BOND-III
24 Jun 2021
IVDs, cytopathology & histopathology
Model: 49.0051 & 21.2201
MHRA reference: 2021/006/025/601/504
Medline International France: QuickSuite
25 June 2021
Surgical drapes, gowns, masks
MHRA reference: 2021/006/025/487/008
Ortho Clinical: VITROS Chemistry Products CKMB Slides
24 June 2021
IVDs, clinical chemistry
Model: 8058232 & 8001133
MHRA reference: 2021/006/024/601/501
Roche Diagnostics: Cobas u pack
SBN-RDS-CoreLab-2021-009
IVDs, clinical chemistry
MHRA reference: 2021/006/024/000/002
Siemens Healthcare: Atellica CH 930 Analyzer
May 2021
IVDs, clinical chemistry
Model: 11067000
MHRA reference: 2021/005/025/601/502
Synopsys Northern Europe: Simpleware ScanIP Medical
18 June 2021
Picture archiving and communication system (PACS)
Model: NA
MHRA reference: 2021/006/018/601/500
Thermo Fisher Scientific: ThermoScientific Oxoid AMC30 Amoxycillin / Clavulanic Acid Antimicrobial Susceptibility Discs
02 June 2021
IVDs, Bacteriology
MHRA reference: 2021/006/023/601/005