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
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View . FSNs before this date are on the
ArjoHuntleigh: IndiGo Intuitive Drive Assistance
26 May 2021
Bed and accessories
Model: INDI-XXX
MHRA reference:
bioM茅rieux: ETEST IMIPENEM RELEBACTAM-WW & US
01 July 2021
IVDs, bacteriology
Model: ETEST
MHRA reference:
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:
Ethicon: INTERCEED Absorbable Adhesion Barrier
GYNECARE INTERCEED Clinical Study Results Wound management
MHRA reference:
Leica Biosystems Newcastle: BOND-MAX & BOND-III
24 Jun 2021
IVDs, cytopathology & histopathology
Model: 49.0051 & 21.2201
MHRA reference:
Medline International France: QuickSuite
25 June 2021
Surgical drapes, gowns, masks
MHRA reference:
Ortho Clinical: VITROS Chemistry Products CKMB Slides
24 June 2021
IVDs, clinical chemistry
Model: 8058232 & 8001133
MHRA reference:
Roche Diagnostics: Cobas u pack
SBN-RDS-CoreLab-2021-009
IVDs, clinical chemistry
MHRA reference:
Siemens Healthcare: Atellica CH 930 Analyzer
May 2021
IVDs, clinical chemistry
Model: 11067000
MHRA reference:
Synopsys Northern Europe: Simpleware ScanIP Medical
18 June 2021
Picture archiving and communication system (PACS)
Model: NA
MHRA reference:
皇冠体育apprmo Fisher Scientific: 皇冠体育apprmoScientific Oxoid AMC30 Amoxycillin / Clavulanic Acid Antimicrobial Susceptibility Discs
02 June 2021
IVDs, Bacteriology
MHRA reference: