Field Safety Notices: 21 to 25 February 2022
List of field safety notices (FSNs) from medical device manufacturers from 21 to 25 February 2022.
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.
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BrainLab: ExacTrac Dynamic
07 February 2022
Radiotherapy planning and verification systems
MHRA reference:
CamDiab: CamAPS
11 February 2022
Software as a medical device (SaMD)
Model: FX
MHRA reference:
Cipher Surgical: OpClear Disposable Procedure Kit CS-SZ10-00, CS-SZ10-30, CS-SR10-00, CS-SR10-30
16 February 2022
Endoscopes, rigid
MHRA reference:
Hillrom: UNIVERSAL TWINBAR 670 3156087 P3156087
21 February 2022
Hoists and slings
MHRA reference:
Philips: Azurion R2.0.x
08 February 2022
X Ray, fluoroscopy systems
Model: 722079
MHRA reference:
Qiagen: NeuMoDx Cartridge
February 2022
IVDs, SARS-CoV-2 PCR test
MHRA reference:
Stryker: CLAW II ORTHOLOC 3DSi Plate/DARCO Screw, Locking
February 2022
Osteosynthesis, bone screws
Model: 40240430 -CLAW II Ortholoc 3DSi Plate, 4 Hole 30mm x 30mm
MHRA reference:
Sysmex: FLUOROCELL PLT
03 February 2022
IVDs, haematology
MHRA reference: