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
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View . FSNs before this date are on the
Abbott: Neuro皇冠体育apprm NT2000iX Radiofrequency (RF) Generator
26 May 2021
皇冠体育apprapy tissue ablation
Model: RFG-NT-2000
MHRA reference:
B.Braun Medical: Caresite Extension Set
26 May 2021
Infusion & transfusion, administration sets
MHRA reference:
BioM茅rieux: Sabouraud 2 agar (SAB2-T)
27 May 2021/FSCA 5201
IVDs, bacteriology
MHRA reference:
BioM茅rieux: VIDAS Anti-HBs Total II
03 June 2021/FSCA 5202
IVDs, viral microbiology
MHRA reference:
Brainlab: ExacTrac Dynamic
29 April 2021
Radiotherapy planning and verification
Model: 20910-01
MHRA reference:
ConMed: Buffalo Filter LaparoVue Visibility System
24 May 2021
Endoscopes, rigid
MHRA reference:
Hill-Rom: Affinity 4 Birthing Bed
MOD 1331
Beds and accessories
Model: Frames (P3700B, P3700C, P3700D, & P3700E)
MHRA reference:
Integra LifeSciences: Codman Bactiseal EVD Catheter Set
08 October 2020
Cerebrospinal fluid drainage, external
Model: 821750; 821749
MHRA reference:
iQ HealthTech: iQemo chemotherapy prescribing system
02 May 2021
Drug dosage calculator
MHRA reference:
ITP Innovative Tomography Product: Interventional Needle KIM/KIR, Biopsy Needle BIM
20 April 2021
Surgical instruments, minimal access
MHRA reference:
脰ssur: Miami J Select
May 2021
Orthoses
MHRA reference:
Randox Laboratories: NEFA (Non-esterified fatty acid)
10 May 2021/REC 527
IVDs, clinical chemistry
MHRA reference:
Randox Laboratories: RX Imola
21 April 2021/REC513
IVDs, clinical chemistry
Model: RX4900 & RX4900R
MHRA reference:
Roche Diagnostics: Cobas 6500
May 2021
IVDs, clinical chemistry
MHRA reference:
皇冠体育apprapy Equipment: Diamond High Suction Controller
24 May 2021
Surgical equipment, miscellaneous
Model: 7701, 7705, 7852
MHRA reference:
Tyromotion: Lexo
25 May 2021
皇冠体育apprapy, standing & walking
MHRA reference: