Field Safety Notices: 22 to 26 April 2024
List of Field Safety Notices from 22 to 26 April 2024.
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 . FSNs before this date are on the
ACE MEDICAL DEVICES: 聽BLADDER EVACUATOR聽
03 April 2024
Bladder evacuator, single-use聽
Model: Universal 聽
MHRA reference: 听听听听
B Braun: ACETABULAR AND HEAD IMPLANTS
22 April 2024
Non-constrained polyethylene acetabular line
Model: NV302E; NV315ENV304E听听
MHRA reference: 听听听听
Baxter: ProBP 3400, Spot Vision Screener and Power Cords
24 April 2024
MHRA reference: FSN听听听听
MHRA reference: 尝别迟迟别谤听听听
Beckman Coulter: DxI 9000 Access Immunoassay Analyzer聽
24 April 2024
Chemiluminescent immunoassay analyzer IVD
Model: C11137
MHRA reference: 听听
Cadwell: Cascade IOMAX Cortical Module
23 April 2024
Neurophysiologic monitoring system聽
MHRA reference: 听听听听
Draeger: Infinity Acute Care System (M540)聽
April 2024
Physiological Monitoring Systems
Model: MS20407听听
MHRA reference: 听听听听
Elekta: Disposable Biopsy Needle Kit聽
April 2024
Stereotactic Surgery System, Neurological聽
Model: 911933 50398-01, 307165, 60377-02, 60377-01, 50376-01, 14001050, 1002248聽
MHRA reference: 听听听听
Getinge: Flow-i C20, Flow-i C30, Flow-i C40, Flow-c, Flow-e
23 April 2024
Anesthesia system
MHRA reference: 听听听听聽
HORIBA: ABX Pentra Urea CP
25 March 2024
Urea IVD, reagent
Model: A11A01641 / 1220001641聽
MHRA reference: 听听听听听听
Intersurgical: Various Mapleson F Anaesthetic Breathing Systems聽
24 April 2024
Anaesthesia breathing circuit, single-use
MHRA reference: 听听听听
Intuitive: SureForm45/60, Cannula Seal, Arm Drape, Obturator聽
19 March 2024
Robotic Surgical System聽
Model: 480445-04; 480460-09; 470015-07, 420023-03, 470361-08聽
MHRA reference: 听听听听
Medline: Electrosurgical Electrode
FSN 24-02
MHRA reference: 听听听听
Medtronic: Catheter, Dilation - 30mm
April 2024 FA1413
Gastrointestinal/biliary dilation balloon catheter聽
Model: ES-330听听
MHRA reference: 听听听听
Philips: Igenia with Evolution Upgrade
19 April 2024
Magnetic Resonance Imaging (MRI) unit
Model: 782116, 782117
MHRA reference: 听听听听
Philips: PIC iX, PIC iX Expand聽
2024-CC-HPM-013
Model: 866389, 866390聽
MHRA reference: