Field Safety Notices: 21 to 25 June 2021
Summary list of field safety notices (FSNs) from medical device manufacturers from 21 to 25 June 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.
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B Braun Medical: EV3.0 Kamerakon Trolleinheit
24 June 2021
Endoscopes, televisual systems
Model: PV630
MHRA reference:
BioM茅rieux: BCID and BCID2 Panel
01 February 2021/FSCA 5046
IVDs, bacteriology
Model: RFIT-ASY-0127, RFIT-ASY-0126 (BCID)/ RFIT-ASY-0147 (BCID2)
MHRA reference:
BioMerieux: PN plus Panel
16 June 2021/FSCA 5183
IVDs, bacteriology
Model: RFIT-ASY-0142 and RFIT-ASY-0143
MHRA reference:
BioM茅rieux: Sabouraud 2 agar (SAB2-T)
05 May 2021/FSCA 5172
IVDs, bacteriology
MHRA reference:
C.G.M: Impacted Batches
03 May 2021
Surgical instruments, non articulated cutting
Model: Safescraper Twist Curve, Safescraper Twist, Micross, Smartact Pin, Magic Ma
MHRA reference:
Ethicon Endo-Surgery: Powered Plus Articulating Endoscopic Linear Cutter
PSEE20
Staples and staple guns
MHRA reference:
Medical Wire & Equipment: Dryswab
11 June 2021
IVDs, SARS-CoV-2 PCR test
Model: MW012
MHRA reference:
Philips Health Systems: Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent
2021-05-A
Lung ventilators
Model: BiPAP V30, and BiPAP A30/A40 Series Device Models
MHRA reference:
Primerdesign: PROmate COVID-19 assay/q16 instrument /software version 2.10.2
30 March 2021
IVDs, SARS-CoV-2 PCR test
Model: D00050
MHRA reference:
Raumedic: NEUROVENT-P-tel
10 June 2021
Implantable EEG
Model: 096504-001
MHRA reference:
Sony Corporation: LCD Monitor
June 2021
Endoscopes, televisual systems
Model: LMD-X2700MD / LMD-X2705MD / LMD-X2705N
MHRA reference:
Surgical Holdings: Kirschner Wire & Arthrodesis Wire
21 June 2021
Osteosynthesis, skeletal pins, wires & staples
MHRA reference:
Tornier: Aequalis Ascend Flex Reversed Tray
28 May 2021
Joint prosthesis, shoulder
Model: Reversed Tray (+)0 Thickness, 1.5mm Offset
MHRA reference:
Xiros: CC-Hook Right
16 June 2021
Sutures
Model: 202-1413
MHRA reference: