Field Safety Notice: 22 to 26 July 2019
Summary List of field safety notices (FSNs) from medical device manufacturers from 22 to 26 July 2019.
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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Apollo Endosurgery: BIB/Orbera365 Intragastric Balloon Systems
July 2019
Implants, non-active, gastrointestinal B-40800, B-50012
MHRA reference:
B Braun: PERIFIX FILTER 0.2~M ISO NRFit
04 July 2019
Infusion & transfusion, administration sets
MHRA reference:
Becton Dickinson: BD Max Reagents
17 July 2019
IVDs, bacteriology
MHRA reference:
Becton Dickinson: Gateway Workstation and Gateway Workstation Web Browser User Interface
July 2019
Infusion systems Model: Gateway Workstation: 80203UNS02-xx, 80203UNS03-xx and 80300UNS02-xx
MHRA reference:
CooperSurgical: TransWarmer Warming Infant Transport Mattress
24 June 2019
Infant, warmers Model: 20421
MHRA reference:
Edwards Life Sciences: Edwards Ultra Delivery System
FCA 141
Implants, non-active, cardiovascular heart valves 9630TF20, 9630TF23, 9630TF26, 9630TF29
MHRA reference:
Electromedical Products International: Alpha Conducting Solution
09 July 2019
Therapy, electrotherapy Model: ACS, ACSR (Refill)
MHRA reference:
EMED SP: RF electrosurgical unit for arthroscopy
20 May 20109
Surgical instruments, minimal access
MHRA reference:
Getinge: Steam sterilizer
27 June 2019
Sterilizers, steam (Autoclaves) CPS, GE, GEB, GEC, GED, GEF, GEL, GEV, GSS67, HS66, HS44, HS55, HS69, HS71, HS81
MHRA reference:
Hitachi: Cobas, C, E, Pro & 8000 Module/Analyser/Analytical Unit
July 2019
IVDs, clinical chemistry
MHRA reference:
Medline: MED-SEMI RIGID Liner 3.0L
18 July 2019
Surgical suction
MHRA reference:
Ortho Clinical Diagnostics: ORTHO VISION and VISION Max Analyzers
July 2019
IVDs, blood transfusion Model: 6904579 and 6904578
MHRA reference:
QIAGEN: QIAsymphony SP
16 July 2019
IVDs, viral microbiology
MHRA reference:
Randox: Urinalysis Control Level 2
17 July 2019
IVDs, Clinical chemistry
MHRA reference:
Siemens: SOMATOM Force, Drive, Confidence
14 June 2019
Computed tomography 8098027, 10430603, 10742326, 10431700, 10590000, 10590100, 10267000
MHRA reference:
Stryker: Brand
14 June 2019
Joint prosthesis, hip Model: LFIT Anatomic CoCr V40 Femoral Heads
MHRA reference:
Thermo Fisher: Remel
18 July 2019
IVDs, bacteriology Model: R30855201
MHRA reference: