Field Safety Notices: 22 to 26 February 2021
List of field safety notices (FSNs) from medical device manufacturers from 22 to 26 February 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
Acutronic: fabian HFO and fabian +nCPAP evolution
18 February 2021
Lung Ventilators
Model: fabian HFO:111001, 111001.01, 112001, 113001
MHRA reference: 2021/002/024/291/008
Baxter: Prismaflex Control Unit
09 February 2021
Dialysis, haemofilters
Model: 107493. • 113082, • 113874, • 114489, • 114870 • 955052, • G5010007, • G5064801, • G5006203
MHRA reference: 2021/002/008/487/006
BD: Venflon Pro Safety I.V. Cannula
01 March 2021
Vascular Cannula And Catheters
Model: Venflon Pro Safety I.V. Cannula
MHRA reference: 2021/002/018/291/010
Brainlab: ExacTrac Dynamic
10 February 2021
Radiotherapy Planning and Verification Systems
Model: 20910-06
MHRA reference: 2021/002/024/291/007
DiaMed: DiaClon anti-N and DiaClon anti-M/N
24 February 2021
IVDs, Haematology
Model: 007111 and 006011
MHRA reference: 2021/002/025/601/002
Immucor: MatchIt! DNA Software
17 February 2021
IVDs, Immunology
Model: V1.2 and V1.3
MHRA reference: 2021/002/023/601/005
Leica: BOND Ready-To-Use Primary Antibody CD19 (BT51E)
18 February 2021
IVDs, Clinical Chemistry
Model: Novocastra liquid mouse monoclonal antibody CD19
MHRA reference: 2021/002/018/601/004
Likamed: SELEXA ; SELEXA / keine
Beds and accessories
Model: SELEXA ; SELEXA / keine
MHRA reference: 2021/002/019/487/001
Philips: HeartStart FR2+ AED, HeartStart FRx AED, HS1 (Onsite) AED, HS1 (Home) AED
23 February 2021
Defibrillators, Non Implantable
Model: FR2+: M3840A, M3841A, M3860A, M3861A, 861364, 861365, 861372, 861373, 861374, 861375, 861458, 861459. FRx : 861304, 861305
MHRA reference: 2021/002/025/291/001
RaySearch: Radiation Therapy Treatment Planning System
19 February 2021
Radiotherapy Planning And Verification Systems
Model: RayStation 4.5, 4.7, 4.9, 5, 6, 7, 8A, 8B, 9A, 9B, 10A, 10B, RayPlan 1, 2, 7, 8A, 8B, 9A, 9B, 10A, 10B, including some of the service packs
MHRA reference: 2021/002/024/291/006
Stryker: LIFEPAK® CR2 DEFIBRILLATOR
26 February 2021
Defibrillators, Non Implantable
Model: CR2-2-000XXX
MHRA reference: 2021/002/018/487/001