Field Safety Notices: 11 to 15 July 2022
Summary List of field safety notices (FSNs) from medical device manufacturers from 11 to 15 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
Becton Dickinson: Venflon Pro Safety (VPS) Needle Protected IV C
14 July 2022
Vascular Cannula And Catheters
Model: 393222; 393224; 393226; 393227; 393228; 393229; 393230
MHRA reference: 2022/007/011/596/007
BioIntegral: BioIntegral Surgical No-React(R)
14 July 2022
Implants, Non Active, Cardiovascular Heart Valves
Model: NRAC, NRPC, NRA, NRM, NRIP
MHRA reference: 2022/004/021/291/004 (original FSN)
The manufacturer has issued an updated Follow-up FSN. The updated Follow-up FSN has the same date (2022-07-14) as the original Follow-up FSN, however, the manufacturer has added both additional text within the Update section and included a hyperlink to a separate document which provides a summary of test results and discussion
bioMérieux: NUCLISENS easyMAG Magnetic Silica
07 July 2022
IVDs, Viral Microbiology
MHRA reference: 2022/007/011/596/008
Boston Scientific: ZOOM Latitude Programmer
July 2022
Implants, Active, Cardiac Programmers and Remote Monitoring
Model: 3120
MHRA reference: 2022/007/012/291/014
GE: Tables used with CT, PET and NM systems
Ref 22998
Computed Tomography
MHRA reference: 2022/007/013/596/001
Getinge: Servo-u / Servo-u MR / Servo-n
22 June 2022
Lung Ventilators
MHRA reference: 2022/007/012/222/001
Getinge: Servo-air
MX-8641
Lung Ventilators
Model: Servo-air ventilator system, Servo-u ventilator system, Servo-n ventilator system, Servo-u MR ventilator system
MHRA reference: 2022/006/028/613/010
Getinge: Servo-u, Servo-n, Servo-u MR and Servo-air
MX-8664
Lung Ventilators
Model: Servo-u ventilator system
MHRA reference: 2022/006/024/595/003
Invacare: BEN NG Self-Propelling
10 June 2022
Wheelchairs, Manual
MHRA reference: 2022/006/010/701/028
Medicina: ENfit reusable enteral syringes and single-use and reusable oral tip syringes
15 June 2022
Feeding Systems And Tubes
Model: LHE01LD, LHE25LD, LHE05, OT005, OT01, OT25, OT05, OTH01, OTH25, OTH0
MHRA reference: 2022/006/022/601/503
Ortho Clinical Diagnostics: Blood Grouping Reagent Anti-Lea (Anti-LE1)
30 June 2022
IVDs, Blood Transfusion
MHRA reference: 2022/007/007/601/006
Renishaw: neuroinspire surgical planning software
01 July 2022
Surgical Navigation System and Accessories
MHRA reference: 2022/007/004/701/003
Siemens: AXIOM Sensis XP/ Sensis/ Sensis Lite/ Vibe Combo
July 2022
Electrophysiology Measurement
MHRA reference: 2022/007/011/601/501
Siemens: Atellica CH Iron_2
June 2022
IVDs, Clinical Chemistry
MHRA reference: 2022/007/008/601/502
Smiths Medical: Level 1® H-2 Pressure Chamber, Level 1® Pressure Chamber Door and Latch Replacement Kit, Latch Assembly H-2 Plus, Door Assembly H-2 Plus
This FSN has been replaced with an updated FSN issued by the manufacturer on 8 August 2022
Stryker: 2.3MM TAPERED ROUTER
July 2022
Surgical Power Tools
MHRA reference: 2022/007/001/599/001
Updates to this page
Last updated 8 August 2022 + show all updates
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Updated entry for BioIntegral: BioIntegral Surgical No-React(R): The manufacturer has issued an updated Follow-up FSN. The updated Follow-up FSN has the same date (2022-07-14) as the original Follow-up FSN, however, the manufacturer has added both additional text within the Update section and included a hyperlink to a separate document which provides a summary of test results and discussion.
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First published.