Field Safety Notices - 30 March to 3 April 2020
Summary list of field safety notices (FSNs) from medical device manufacturers from 30 March to 3 April 2020
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 the latest
AVANOS: CORFLO* PEG Kit with ENFit庐 Connector
27 March 2020
Feeding systems and tubes
MHRA reference:
Biomet (Zimmer): Comprehensive Reverse Shoulder System
31 March 2020
Joint prosthesis, shoulder
MHRA reference:
Biomet (Zimmer): Coonrad-Morrey Pin and Bushing Kit SML/REG E1
26 March 2020
Joint prosthesis, elbow
MHRA reference:
Biomet (Zimmer): Comprehensive
2 April 2020
Orthopaedic surgical instruments - insertion/extraction tools
MHRA reference:
Blue Belt Technologies (Smith+Nephew): NAVIO Soft Tissue Protector
3 March 2020
Orthopaedic surgical instruments - measuring tools
MHRA reference:
Boston Scientific: GreenLight 0010-2400 MoXy Laser Fiber
March 2020
皇冠体育apprapy, lasers
MHRA reference:
Bucher Leichtbau: EMS Stretcher PN: 1354100,
00927/19 2019-02-01
Stretchers
MHRA reference:
Canon Medical Systems: Interventional Angiography System
30 Match 2020
X ray, fluoroscopy systems
Model: INFX-8000C & INFX-8000V
MHRA reference:
Inpeco A3600: Accelerator A3600
23 March 2020
IVDs, clinical chemistry
MHRA reference:
Inpeco Aptio: Aptio Automation
23 March 2020
IVDs, clinical chemistry
MHRA reference:
Inpeco: FlexLab
23 March 2020
IVDs, clinical chemistry
MHRA reference:
Intervascular: Hemashield Gold 鈥� Hemashield Platinum
25 March 2020
Implants, non active, endoprostheses for aortic aneurysms
MHRA reference:
Mercado Medic: Real 9000 plus
S02461
Supportive seating
MHRA reference:
Merit Medical: PreludeSYNC DISTAL
1721504-03/06/20-001R
Surgical equipment, tourniquets
MHRA reference:
Natus: Aircal
CAPA004808
Surgical equipment, miscellaneous
Model: 8-04-13310, 8-04-13321, 8-04-13322
MHRA reference:
NuVasive
1 April 2020
Spinal implants
Model: MAGEC 1, MAGEC 1.5, MAGEC 2, MAGEC 2B (or MAGEC X)
MHRA reference:
Ortivus: CoroNet MobiMed
13 February 2020
Monitors, patient
MHRA reference:
SenTec AG: Sentec Digital Monitored System
2 May 2019
Monitors, patient
MHRA reference:
Siemens: Atellica CH 930 Analyzer
February 2020
IVDs, clinical chemistry
MHRA reference:
Synaptive Medical: ClearCanvas RIS/PACS
March 2020
Picture archiving and communication system (PACS)
Model: Version 3.0 and higher
MHRA reference: