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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
None
Section 2: medical devices 05 to 09 August 2024
- Boston Scientific Corporation: WallFlexTM Esophageal Stent System AgileTM Esophageal Over the Wire (OTW) Stent System 45505 WallFlex & Agile Esophageal Stent Systems Polymer-metal oesophageal stent, non-sterile MHRA reference: 31402807 2024/008/001/601/065
- Cook Medical Europe Ltd.: Rabinov Sialography Set, Fanelli Cholangiography Catheter Set, BiWire® Nitinol Core Wire Guide with Hydrophilic Coating 45511 Reference Part Numbers (RPNs): SCS-P-16-L, C-FCC-100, BW-035150, and BWS-035150 Order Numbers (GPNs): G01346, G12950, G46141, and G46138, respectively MHRA reference: 31425069 – Customer reply form 2024/008/005/601/055 MHRA reference: 31425069 – Letter
- Sysmex Corporation Japan: XF-1600 45495 Flow cytometry analyser IVD Model: all MHRA reference: 31424770 2024/008/005/601/011
- Nutricia Medical Devices BV: Flocare Infinity III 45506 Flocare Infinity III enteral feeding pump Model: 202320912028 to 202328312208 Concerned EU AC plug heads, LOT- KRAD28H MHRA reference: 31415195 2024/008/002/601/039
- Cookson Precious Metals Ltd: Dental Alloys and Solders 45505 MHRA reference: 31414685 2024/008/002/601/047
- Medtronic: Flexya Dialysis Machine Net Fluid Removal 45474 Haemodialysis system, institutional Model: IBN03X700, IBN03X701 MHRA reference: 31401975 – Letter 2024/008/001/601/066 MHRA reference: 31401975 – Customer acknowledgement form
- Beckman Coulter, Inc.: Power Express Centrifuge 45499 Specimen processing instrument IVD, automated Model: B90918; B36365; B36366 MHRA reference: 31401796 – Letter MHRA reference: 31401796 – Vigilance response form 2024/008/001/601/035
- Philips: Allura Xper R8.1 System with Poly-G Stand 45504 Stationary general-purpose fluoroscopic x-ray MHRA reference: 31401972 2024/008/001/601/015
- B. Braun Medical Ltd: MONOPLUS 45509 MONOPLUS VIOLE 1(4)150CM HR48 LOOP(M)DDP Model: 124243 MHRA reference: 31440080 2024/008/006/601/046
- GE HealthCare: Centricity Universal Viewer Zero Footprint client Medical Image Management System Model: v6.0 SP9.x and SP10.x MHRA reference: 31438792 2024/008/006/601/069
- Revvity: Prenatal BoBs 45510 Model: 3100-0020; 3100-002Z (China specific version) MHRA reference: 31436990 2024/008/006/601/042
- Philips: Update FSN – Achieva 1.5T, Achieva 1.5T Conversion, Ingenia 1.5T CX, Intera 1.5T, Intera 1.5T Power/Pulsar, SmartPath to dStream for 1.5T 45470 Magnetic Resonance Imaging (MRI) unit Model: 781105, 781195, 781295, 781178, 781196, 781296, 781343, 781283, 781346, 781261, 781262, 781260, 782112 MHRA reference: 31453581 2023/010/025/601/095
- Philips: Azurion System R1.x 45484 Interventional Fluoroscopic X-Ray System MHRA reference: 31452704 2024/007/015/601/042
- Philips: SENSE XL Torso (1.5T and 3.0T) Coils 45443 Magnetic Resonance Imaging (MRI) unit MHRA reference: 31452607 2024/006/006/601/057
- Beckman Coulter, Inc.: Access HBc Ab Reagent 45509 Model: 34240 LOT. 494328 MHRA reference: 31445684 – Letter 2024/006/010/601/023 MHRA reference: 31445684 – Vigilance response form
- Ossur: Miami J® Select 45474 Cervical spine immobilizer/collar Model: see Appendix A – Impacted Lot Numbers MHRA reference: 31447119 – Letter 2024/008/007/601/045 MHRA reference: 31447119 – Customer acknowledgement form
- Boston Scientific: Vercise Genus™ Implantable Pulse Generator System 45512 Deep brain electrical stimulation system Model: DB-1216 and DB-1232 MHRA reference: 31457499 2024/008/008/601/067
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.
Section 3: updates and changes to previously published medical device FSNs
| Page summary | Change(s) made |
| n/a | n/a |
Adverse Incidents
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)
Facilities Division
NHSScotland Assure
NHS National Services Scotland
Tel: 0131 275 7575|nss.iric@nhs.scot | Report an incident | Find safety alerts | IRIC | Turas Learn
We are NHS National Services Scotland. We offer a wide range of services and together we provide national solutions to improve the health and wellbeing of the people of Scotland. Find out more about our services at www.nss.nhs.scot
FAC406-212, 8B(i), Rev 7
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