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 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
Last updated 6 March 2023 + show all updates
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Ceannaire Medical: Obstetric Suction Cup has been removed from the list.
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First published.