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Manufacturers’ Field Safety Notices
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This message is sent to share information on manufacturers’ field safety notices (FSNs) which have been brought to our attention. Manufacturers have a legal duty to distribute these notices to affected customers.
This message does not affect the manufacturer’s FSN distribution, but it provides a reference source to check against.
You should always contact your supplier or the manufacturer if you are affected by a field safety notice listed below but have not received it from them. This will help ensure that you are not also missed from future FSN distributions. Note that field safety notices will only be listed in the sections below if we have been made aware of them.
Section 1 below lists selected FSNs and other relevant safety updates for estates, facilities or general products which have been brought to our attention through various sources including Office for Product Safety and Standards (OPSS). Section 2 lists FSNs for medical devices brought to our attention specifically by Medicines and Healthcare products Regulatory Agency (MHRA).
Section 1: estates, facilities or general products
Section 2: medical devices 20/02/23 – 24/02/23
- CareDx: Olerup QTYPE 11 44979 MHRA reference: 5084647
- Ceannaire Medical: Obstetric Suction Cup 44839 Surgical Manipulators Model: HK-TT-Q-A, HK-TT-Q-B MHRA reference: 5083539
- CooperSurgical: Sage Vitrification Media Kit 44980 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 44907 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 44977 Artificial Ventilation Device For Intensive Care Model: 160021 MHRA reference: 5083228
- Helena Biosciences: ProtoFluor-Z Reagent Kit 44967 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 44965 Shoulder glenoid fossa prosthesis, prefabricated Model: 1379.59.210 MHRA reference: 5088315
- Philips: SmartPerfusion OWB; 2D Perfusion OWB 44977 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 44973 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 44967 MHRA reference: 5082063
- Siemens Healthineers: ADVIA 2120/2120i Hematology System w Autoslide SMS 44958 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
The above list of FSNs for medical devices is copied from the relevant MHRA web page. If you wish to browse or search for FSNs on the MHRA website, please click here.
Incidents and near-misses should always be reported to local incident management systems (often referred to as Datix, Ullyses, SHE, etc.). However, IRIC also needs to be informed about incidents and near-misses when they involve:
- Medical devices, e.g. infusion pump, central line, hoist, care bed, x-ray machine, ventilator
- In vitro diagnostic devices or IVDs, e.g. blood analyser, reagent, SARS-CoV-2 test kit
- Estates and facilities, e.g. electrical installations, window restrictors, nurse call systems
- Social care equipment, e.g. mobile wheeled commode, powered rise and recline chair
- Personal protective equipment or PPE, e.g. visors, FFP3 respirators, aprons
We need incident reports so we can work with manufacturers and our partners to stop the same thing happening again. Health and care professionals can also report safety concerns about equipment and devices when an incident or near-miss has yet to occur. Information about how to report an incident to IRIC can be found here: https://www.nss.nhs.scot/health-facilities/incidents-and-alerts/report-an-incident/
Incident Reporting & Investigation Centre (IRIC)
Health Facilities Scotland
NHS National Services Scotland
IRIC Email email@example.com
Helpline 0131 275 7575
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NHS National Services Scotland is the common name for the Common Services Agency for the Scottish Health Service. www.nhsnss.org
FAC406-015, 8B(i), Rev 6