Field Safety Notices: 20 to 24 February 2023

List of Field Safety Notices (FSNs) from 20 to 24 February 2023

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.

CareDx: Olerup QTYPE 11

22 February 2023

MHRA reference: 5084647

CooperSurgical: Sage Vitrification Media Kit

23 February 2023

IVF Medium Kit

Model: ART-8026A

MHRA reference: 5083079

CooperSurgical: Global Total LP single step medium, 60mL

1216677-2-12-2023-002-R 23 February 2023

IVF Medium

MHRA reference: 5083220

DePuy Synthes: BIOSTOP G Bioresorbable Cement Restrictor

12 December 2022

Polymer orthopaedic cement restrictor

Model: 546-30-8000 546-31-0000 546-31-2000 546-31-4000 546-31-6000 546-31-8000 546-32-0000

MHRA reference: 5086298

Hamilton Medical: HAMILTON-C6

20 February 2023

Artificial Ventilation Device For Intensive Care

Model: 160021

MHRA reference: 5083228

Helena Biosciences: ProtoFluor-Z Reagent Kit

10 February 2023

Protoporphyrin IX IVD, calibrator

MHRA reference: 5081937

Helena Biosciences: Thromboplastin L, PT

NC 647 10 February 2023

Prothrombin time (PT) IVD, kit, clotting

Model: 5265L, 5267L, OL262501, OL762501, OL962501

MHRA reference: 5088309

Intuitive: da Vinci X and da Vinci Surgical System

ISIFA2022-13-C

Robotic Surgical System

Model: IS4000 Surgical System; IS4200 Surgical System

MHRA reference: 5081838

LimaCorporate: TT HYBRID CEM. GLENOID STD

08 February 2023

Shoulder glenoid fossa prosthesis, prefabricated

Model: 1379.59.210

MHRA reference: 5088315

Philips: SmartPerfusion OWB; 2D Perfusion OWB

20 February 2023

Interventional Fluoroscopic X-Ray System

Model: 722003, 722006, 722008, 722010, 722012722013, 722020, 722023, 722026, 722027722028, 722029, 722035, 722038, 722039722058, 722059, 722064, 722067, 722068722078, 722079, 722223, 722224, 728225722226, 722227 and 722228

MHRA reference: 5083476

RaySearch Laboratories: RayStation

16 February 2023

Various Radiotherapy Instruments – Software

Model: RayStation, RayPlan 9A, 9B, 10A, 10B, 11A, 11B and 12A including service packs

MHRA reference: 5083499

SD Biosensor: STANDARD F C.difficile Toxin A/B FIA

10 February 2023

MHRA reference: 5082063

Siemens Healthineers: ADVIA 2120/2120i Hematology System w Autoslide SMS

February 2023

Giemsa staining solution IVD

Model: ADVIA Autoslide Giemsa Stain

MHRA reference: 5088336

Terumo: Capiox Oxygenators/Reservoirs

FSN 2202 2023-02

Oxygenators, Extracorporeal Membrane

Model: 3CXFX25RWC / 3CXFX25REC

MHRA reference: 5086273

Updates to this page

Published 27 February 2023
Last updated 6 March 2023 + show all updates
  1. Ceannaire Medical: Obstetric Suction Cup has been removed from the list.

  2. First published.