Field Safety Notices: 20 to 24 December 2021
List of field safety notices (FSNs) from medical device manufacturers from 20 to 24 December 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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Abbott FSN 241221: HT Command 18 ST Guide Wire
FSN 241221
Vascular cannula/catheter accessories
MHRA reference:
Abbott FA-AM-DEC2021-263: Alinity M System
06 December 2021
IVDs, clinical chemistry
Model: Instrumentation/ Platform
MHRA reference:
Abbott Molecular: Alinity M System
06 December 2021
IVDs, clinical chemistry
Model: Alinity m system
MHRA reference:
B Braun: Monoplus Violet 1 (4)150CM HRT40S(M)LOOP
15 December 2021
Sutures
MHRA reference:
Batec: Mobility
01 December 2021
Wheelchairs, powered
Model: 92 articles were affected, see list in FSN
MHRA reference:
Beaver Visitec International: Xstar and CustomEyes
BVI Malosa Single Use Instrument Procedure Packs
Surgical instruments, non-articulated cutting
Model: 373809 and 588221
MHRA reference:
Boston Scientific: Tome/Autotome RX Family
16 December 2021
Surgical instruments, minimal access
MHRA reference:
Dentsply Sirona: Pathfile; Proglider; Protaper Gold
December 2021
Dental appliances / instruments
Model: PATHFILE STER 25MM/013; PROTAPER GOLD F1 21MM STER; PROTAPER GOLD F2 21MM STER; PROTAPER GOLD F2 25MM STER; PROTAPER GOLD F2 31MM STER; PROGLIDER 6FILE STERILE 25MM MHRA reference:
Dorc: EFTIAR Octane, Vials and Syringes, 5 ml and 7 ml
15 December 2021
Injectable ophthalmic fluids
MHRA reference:
Drager: Fabius MRI
December 2021
Anaesthetic machines & monitors
Model: 8607300
MHRA reference:
GE Vingmed Ultrasound: Vscan Extend
73091
Ultrasound, imaging
MHRA reference:
GE Healthcare 34122: Anaesthesia System
GEHC Ref # 34122
Anaesthetic machines & monitors
Model: Carestation 750 - Carestation 750c
MHRA reference:
Hillrom: Liko M220 & Liko M230
FA 2021-010-002-LUL-001
Hoists and slings
Model: Liko M220 鈥� model 2050010 & M230 鈥� model 2050015 (serial number 5361393-5362761)
MHRA reference:
Intelerad: IntelePACS
15 December 2021
Picture archiving and communication system (PACS)
Model: Enhanced Viewer (EV) and InteleViewer (IV)
MHRA reference:
Medtronic: HeartWare鈩� Ventricular Assist Device (HVAD鈩�) System
December 2021
Implantable ventricular assist devices
Model 1104 - follow-up FSN (FA944) - Update on failure rates and recommendation
MHRA reference:
Medtronic: NIM Trivantage EMG Endotracheal tube
FA1218
Airway devices
Model: 8229705, 8229706, 8229707, 8229708, 8229709, 8229735, 8229736, 8229737, 8229738, 8229739
MHRA reference:
NuVasive: MAGEC System
13 December 2021
Spinal implants
MHRA reference:
Olympus: TJF-Q170V &TJF-Q190V & TJF-Q290
December 2021
Endoscopes, flexible
Model: TJF-Q170V & TJF-Q190V & TJF-Q290V Duodenovideoscopes
MHRA reference:
Oserf: Reusable instruments SERF
23 November 2021
Orthopaedic surgical instruments - insertion/extraction tool
MHRA reference:
Permobil: Tilite
FSCA Ref: CAPA10090
Wheelchairs, manual
Model: ZRA, Areo Z
MHRA reference:
PerkinElmer: DELFIA Xpress hAFP kit
17 December 2021
IVDs, clinical chemistry
Model: 6001-0010, 6001-001C, 6002-0010, 6002-001C, 6003-0020, 6003-002C, 6003-0050, 6003-005C, 6004-0010, 6004-001C
MHRA reference:
Philips: Philips Allura Xper systems
December 2021
X Ray, fluoroscopy systems
MHRA reference:
Siemens Healthcare: Atellica CH 尾2鈥慚icroglobulin
December 2021
IVDs, clinical chemistry
Model: SMN 11097635
MHRA reference:
Siemens Healthineers: Atellica CH and ADVIA Urinary/Cerebrospinal Fluid
September 2021
IVDs, clinical chemistry
MHRA reference:
Fritz Stephan: Sophie
December 2021
Lung ventilators
MHRA reference:
Theradiag SA: I-Tracker Infliximab
20 July 2021
IVDs, clinical chemistry
MHRA reference:
Xstrahl: Concerto 2.x User Interface Software
26 April 2021
Radiotherapy
Model: X80, X100, X150, X200, X300
MHRA reference: