Field Safety Notices: 8 to 12 November 2021

List of field safety notices (FSNs) from medical device manufacturers from Field Safety Notices: 8 to 12 November 2021

If you have a question about a particular FSN contact the manufacturer.

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Abbott Medical: Amplatzer Steerable Delivery Sheath

09 November 2021

Implants, non active, cardiac appendage and septal defect occluders / plugs

Model: ASDS-14F-075

MHRA reference:

bioM茅rieux: VIDAS immuno-assay

03 November 2021/FSCA#5333-1

IVDs, Viral Microbiology

MHRA reference:

bioM茅rieux: RAPID 20 E

09 November 2021/FSCA 5387

IVDs, bacteriology

MHRA reference:

Fannin: Columbia Blood Agar

04 November 2021

IVDs, bacteriology

MHRA reference:

GE Medical Systems: Centricity Universal Viewer Zero Footprint client

GEHC Ref# 85459

Picture archiving and communication system (PACS)

MHRA reference:

GE Healthcare: Centricit High Acuity Anaesthesia/Critical Care

GEHC Ref. # 38008

Picture archiving and communication system (PACS)

MHRA reference:

Human Gesellschaft: IMTEC-Nucleosome-Antibodies

28 October 2021

IVDs, immunology

MHRA reference:

Leica Microsystems: M220 F12

02 November 2021

Surgical equipment, miscellaneous

MHRA reference:

MatOrtho: PIPR

01 October 2021/FSN-21-004

Joint prosthesis, finger

Model: All

MHRA reference:

MatOrtho: SAIPH Total Knee Replacement

01 October 2021/FSN-21-002

Joint prosthesis, knee

MHRA reference:

Medtronic: Puritan Bennett 980 Ventilator System

November 2021/FA1210

Lung ventilator

MHRA reference:

Medtronic: STEALTH AUTOGUIDE TRACKER 28248

November 2021/FA1205

Surgical navigation system and accessories

MHRA reference:

Ortho Clinical: VITROS SARS-CoV-2 Antigen Calibrator

Ref. CL2021-138a

IVDs, SARS-CoV-2 instrumentation antigen test

Model: 6199942

MHRA reference:

Pennine: Ryles, Levins, Feeding tube,Suction, Rectal, Nelaton

11 November 2021

Feeding systems and tubes

MHRA reference:

Siemens Healthcare: BIOGRAPH

CAN 001-2021

PET-CT

Model: 03554461

MHRA reference:

Stryker: Cannulated Compression Screw, Screwdriver Blade

20 October 2021

Orthopaedic surgical instruments - insertion/extraction tools

MHRA reference:

Thermo Fisher Scientific: Thermo Scientific

22 October 2021

IVDs, bacteriology

Model: R30163701

MHRA reference:

Updates to this page

Published 15 November 2021