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