Field Safety Notices: 31 May to 4 June 2021
Summary list of field safety notices (FSNs) from medical device manufacturers from 31 May to 4 June 2021.
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 a list of FSNs published since January 2020
View FSNs since November 2014. FSNs before this date are on the National Archives website
Abbott: NeuroTherm NT2000iX Radiofrequency (RF) Generator
26 May 2021
Therapy tissue ablation
Model: RFG-NT-2000
MHRA reference: 2021/005/027/487/005
B.Braun Medical: Caresite Extension Set
26 May 2021
Infusion & transfusion, administration sets
MHRA reference: 2021/005/027/601/001
BioMérieux: Sabouraud 2 agar (SAB2-T)
27 May 2021/FSCA 5201
IVDs, bacteriology
MHRA reference: 2021/005/027/487/006
BioMérieux: VIDAS Anti-HBs Total II
03 June 2021/FSCA 5202
IVDs, viral microbiology
MHRA reference: 2021/006/002/487/026
Brainlab: ExacTrac Dynamic
29 April 2021
Radiotherapy planning and verification
Model: 20910-01
MHRA reference: 2020/009/024/487/008
ConMed: Buffalo Filter LaparoVue Visibility System
24 May 2021
Endoscopes, rigid
MHRA reference: 2021/005/006/701/027
Hill-Rom: Affinity 4 Birthing Bed
MOD 1331
Beds and accessories
Model: Frames (P3700B, P3700C, P3700D, & P3700E)
MHRA reference: 2021/005/027/487/021
Integra LifeSciences: Codman Bactiseal EVD Catheter Set
08 October 2020
Cerebrospinal fluid drainage, external
Model: 821750; 821749
MHRA reference: 2021/006/002/487/023
iQ HealthTech: iQemo chemotherapy prescribing system
02 May 2021
Drug dosage calculator
MHRA reference: 2021/002/023/401/011
ITP Innovative Tomography Product: Interventional Needle KIM/KIR, Biopsy Needle BIM
20 April 2021
Surgical instruments, minimal access
MHRA reference: 2021/005/025/487/021
Össur: Miami J Select
May 2021
Orthoses
MHRA reference: 2021/005/027/487/007
Randox Laboratories: NEFA (Non-esterified fatty acid)
10 May 2021/REC 527
IVDs, clinical chemistry
MHRA reference: 2021/005/026/601/003
Randox Laboratories: RX Imola
21 April 2021/REC513
IVDs, clinical chemistry
Model: RX4900 & RX4900R
MHRA reference: 2021/005/024/601/504
Roche Diagnostics: Cobas 6500
May 2021
IVDs, clinical chemistry
MHRA reference: 2021/005/027/487/022
Therapy Equipment: Diamond High Suction Controller
24 May 2021
Surgical equipment, miscellaneous
Model: 7701, 7705, 7852
MHRA reference: 2021/006/002/487/021
Tyromotion: Lexo
25 May 2021
Therapy, standing & walking
MHRA reference: 2021/005/018/601/003