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.

Latest FSNs

View the latest FSNs

View a list of FSNs published since January 2020

View FSNs since November 2014.

FSNs before this date are on the National Archives website

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: 2021/011/010/579/010

bioMérieux: VIDAS immuno-assay

03 November 2021/FSCA#5333-1

IVDs, Viral Microbiology

MHRA reference: 2021/011/002/579/010

bioMérieux: RAPID 20 E

09 November 2021/FSCA 5387

IVDs, bacteriology

MHRA reference: 2021/011/008/579/003

Fannin: Columbia Blood Agar

04 November 2021

IVDs, bacteriology

MHRA reference: 2021/011/004/601/001

GE Medical Systems: Centricity Universal Viewer Zero Footprint client

GEHC Ref# 85459

Picture archiving and communication system (PACS)

MHRA reference: 2021/011/010/579/011

GE Healthcare: Centricit High Acuity Anaesthesia/Critical Care

GEHC Ref. # 38008

Picture archiving and communication system (PACS)

MHRA reference: 2021/011/005/579/001

Human Gesellschaft: IMTEC-Nucleosome-Antibodies

28 October 2021

IVDs, immunology

MHRA reference: 2021/011/008/579/001

Leica Microsystems: M220 F12

02 November 2021

Surgical equipment, miscellaneous

MHRA reference: 2021/011/008/579/002

MatOrtho: PIPR

01 October 2021/FSN-21-004

Joint prosthesis, finger

Model: All

MHRA reference: 2021/010/006/601/506

MatOrtho: SAIPH Total Knee Replacement

01 October 2021/FSN-21-002

Joint prosthesis, knee

MHRA reference: 2021/010/006/601/507

Medtronic: Puritan Bennett 980 Ventilator System

November 2021/FA1210

Lung ventilator

MHRA reference: 2021/011/011/579/013

Medtronic: STEALTH AUTOGUIDE TRACKER 28248

November 2021/FA1205

Surgical navigation system and accessories

MHRA reference: 2021/011/010/579/009

Ortho Clinical: VITROS SARS-CoV-2 Antigen Calibrator

Ref. CL2021-138a

IVDs, SARS-CoV-2 instrumentation antigen test

Model: 6199942

MHRA reference: 2021/011/001/601/003

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

11 November 2021

Feeding systems and tubes

MHRA reference: 2021/011/003/579/010

Siemens Healthcare: BIOGRAPH

CAN 001-2021

PET-CT

Model: 03554461

MHRA reference: 2021/011/002/601/501

Stryker: Cannulated Compression Screw, Screwdriver Blade

20 October 2021

Orthopaedic surgical instruments - insertion/extraction tools

MHRA reference: 2021/011/010/579/008

Thermo Fisher Scientific: Thermo Scientific

22 October 2021

IVDs, bacteriology

Model: R30163701

MHRA reference: 2021/011/003/601/001

Updates to this page

Published 15 November 2021