| IRIC | Incident Reporting & Investigation Centre |
Manufacturers’ Field Safety Notices
Circulation
NHS incidents and alerts safety officer
Local authority incidents and alerts safety officers
IRIC product specialists
IRIC alerts general list
Specialist liaison list
Outlook tags IRICSW$i0 (safety alert – general), IRICSW$i5 (field safety notices)
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 06/05/24 – 10/05/24
- Abbott: HeartMate System Monitor 45413 Implantable ventricular circulatory assist system Model: L1286INT, 1286INT, L1286A, L1286, 1286A, 1286 MHRA reference: 30444212
- Alcon: Ophthalmic knives 45415 Ophthalmic knife, single-use MHRA reference: 30435154
- B Braun: AESCULAP AEOS 45415 Neurosurgical microscope Model: PV010 MHRA reference: 30356790
- Bio-Rad: GENIE FAST HIV ½ 45414 HIV1/HIV2 antibody IVD, kit, immunochromatographic MHRA reference: 30362391
- BVI: Beaver 378227 Xstar Safety Slit Knife, 2.75 mm 45422 Ophthalmic knife, single-use Model: 378227 MHRA reference: 30448074
- EOS imaging: oneFIT Total Knee PSI NCR-2023-0068 Joint prosthesis implantation kit, single-use MHRA reference: 30441331
- GE Healthcare: MyoSPECT – MyoSPECT ES Ref. # 40906 Stationary gamma camera system MHRA reference: 30362385
- Illumina: NextSeq 550Dx / MiSeq Dx / NovaSeq 6000Dx 45420 Nucleic acid sequence analyser IVD, NGS MHRA reference: 30356810
- LINK: Endo-Model EVO -W, Femoral Component 45412 Uncoated knee femur prosthesis Model: 15-8542/02; 15-8542/04 MHRA reference: 30357037
- Medicina: Feeding and Aspiration Tubes 45419 Model: LG -NGP – NJP – RT – ST – EF2EL MHRA reference: 30438813
- Medtronic: Various Implantable Cardioverter Defibrillators (ICDs) May 2024 FA1416 MHRA reference: 30446864
- Philips: Incisive CT/CT3500/CT5300 45397 Full-body CT system Model: 728143,728144,728146,728148,728149,728151, 728134, 728138, 728139, 728285 MHRA reference: 30446934
- Stryker: EXETER 2.5 I M PLUG 45413 MHRA reference: 30438814
- The Binding Site: EXENT analyser 45387 Mass spectrometry analyser IVD MHRA reference: 30356793 ….
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 |
| None | 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
——————————————————————————————————————————————————–
This email is intended for the named recipient only. If you have received it by mistake,
please (i) contact the sender by email reply; (ii) delete the email from your system; .
and (iii) do not copy the email or disclose its contents to anyone.
——————————————————————————————————————————————————–