Field Safety Notices: 18 to 22 July 2022
List of field safety notices (FSNs) from medical device manufacturers from 18 to 22 July 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.
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: Assurity, Endurity
July 2022
Implants, Active, Pacemakers
MHRA reference: 2022/007/021/596/003
Ambu: VivaSight 2 DLT
30 May 2022
Airway Devices
MHRA reference: 2022/005/030/701/003
B Braun Medical: Space
19 July 2022
Infusion Systems
MHRA reference: 2022/007/019/601/501
Beaver‐Visitec International: CustomEyes
28 June 2022
Phacoemulsification / Vitrectomy Systems
MHRA reference: 2022/007/012/291/018
Cook Medical: Roadrunner PC Wire Guide
2022FA0002
Vascular Cannula/Catheter Accessories
MHRA reference: 2022/007/020/596/001
GE Healthcare: Centricity High Acuity (CHA) C.C and Anesthesia
Ref 38010
Monitors, Patient
MHRA reference: 2022/007/015/596/007
Intuitive: Generator E-100 374848-09
July 2022
Surgical, Diathermy
MHRA reference: 2022/007/014/701/053
Leica Biosystems: X-TRA Slides
27 June 2022
IVDs, Cytopathology & Histopathology
Model: 3800209
MHRA reference: 2022/007/014/590/003
Medtronic: EverFlex™ Self-Expanding Peripheral Stent with Entrust™ Delivery System
July 2022
Implants, Non Active, Peripheral Vascular Stents
MHRA reference: 2022/007/020/596/013
Philips: V60 Ventilator V60 Plus Ventilator V680 Ventilator
30 June 2022
Lung Ventilators
MHRA reference: 2022/007/019/291/001
Roche: Refer to FSN
July 2022
IVDs, Clinical Chemistry
MHRA reference: 2022/007/008/701/083
Stryker: TRITANIUM BPLATE TRIATHLON
June 2022
Joint Prosthesis, Knee
MHRA reference: 2022/004/021/291/001