Field Safety Notices: 13 to 17 September 2021
List of field safety notices (FSNs) from medical device manufacturers from 13 to 17 September 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.
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
ConvaTec: AQUACEL Ag Dressing and AQUACEL AG+ EXTRA
May 2021
Wound management
MHRA reference: 2021/009/014/291/001
Cook Medical: Inferior Vena Cava (IVC) Filter
15 September 2021
Implants, non active, vena cava filters
MHRA reference: 2021/009/015/487/009
Elekta: Digital Linear Accelerator
August 2021
Radiotherapy
Model: Linac
MHRA reference: 2021/009/015/487/008
Elekta: Monaco
September 2021
Radiotherapy planning and verification systems
MHRA reference: 2021/009/010/291/003
Getinge: Cardiosave Intra-Aortic Balloon Pumps
10 September 2021
Cardiac assist pumps
Model: 0998-XX-0800-XX
MHRA reference: 2021/009/014/291/004
Henry Schein: IV Sets/Accessories
25 May 2021
Infusion & transfusion, administration sets
MHRA reference: 2021/009/015/701/010
Limacorporate: Discovery Elbow - Humeral condyle kit
06 September 2021
Joint prosthesis, elbow
Model: 114991 - 114700
MHRA reference: 2021/009/013/701/026
Microbiologics: Helix Elite SARS-CoV-2 Process Control (Swab)
09 September 2021
IVDs, SARS-CoV-2 PCR Test
Model: HE0063S
MHRA reference: 2021/008/025/701/059
Microbiologics: Helix Elite SARS-CoV-2 Process Control (Pellet)
09 September 2021
IVDs, SARS-CoV-2 PCR Test
Model: HE0062S
MHRA reference: 2021/008/025/701/062
Philips: EPIQ & Affiniti Ultrasound systems
September 2021
Ultrasound, imaging
Model: EPIQ 5G, EPIQ 5C, EPIQ 7G, EPIQ 7C, EPIQ CVx & EPIQ CVxi, Affiniti 30, Affiniti 50, Affiniti 70
MHRA reference: 2021/009/010/291/002
Roche: ONLINE TDM parameters
August 2021
IVDs, SARS-CoV-2 PCR Test
Model: VANC3, GENT2, PHNY2, THEO2, PHNO2
MHRA reference: 2020/011/017/487/002