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Field Safety Notices (FSNs): 18/08/25 – 22/08/25

IRICIncident Reporting &
Investigation Centre

Manufacturers’ Field Safety Notices

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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

1.     Product Recall: Tesco Kind & Pure Facial Cleansing Wipes (2508-0021)

2.     Product Safety Report: Baby Sensory Toys Play Set sold via Etsy (2507-0173 and 2508-0006)

3.     Product Recall: Wacker Neuson BP1000 and BP14000 (2507-0167)

4.     Product Recall: Croydex Devoke Mirror and Croydex Rydal Mirror (2505-0006) updated

5.     Product Safety Report: Playworld Systems Unity Teeter Tunnel (2507-0178)

6.     Child safety: small hazards, big harm

 

Section 2: medical devices 18/08/25 – 22/08/25

  1. Alcon Laboratories, Inc: Alcon Standalone Vitrectomy Consumables 11th August 2025 Model: See Attached Affected Products MHRA reference: 36497952    2025/008/011/601/070
  2. Baxter Medical Systems GmbH + Co. KG: TruSystem 7000 22nd July 2025 Universal Operating Table, Electromechanical Model: 2065385, 1841046, 1841048 MHRA reference: 36501578   2025/007/022/601/060
  3. Bürki inno med AG: Bimanual I/A System single use 13th August 2025 Ophthalmic surgical instrument handle, single use Model: BSD 515 MHRA reference: 36496391   2025/008/007/601/024
  4. DISOP, S.A : SEE FSN 3rd June 2025 Model: SEE FSN MHRA reference: 36521442 
  5. Drägerwerk AG ; Co. KGaA : Atlan Family 45870 Anesthesia Units Model: 8621100, 8621300, 8621400, 8621500, 8621600 MHRA reference: 36488827   2025/008/018/601/072
  6. Epocal Inc.: epoc Host 2 and epoc NXS Host 44896 Metabolic profile clinical chemistry analyser IVD MHRA reference: 36510967   2022/012/023/601/006
  7. GE Healthcare: Enterprise Archive FMI 85486 Please see section 8 Comments MHRA reference: 36501269   2025/008/019/601/068
  8. Getinge Disinfection AB. : Getinge 88-series 15th August 2025 Surgical Utensil Washer/Disinfector Model: 88-Turbo MHRA reference: 36512382    2025/008/020/601/046
  9. Heraeus Medical Components-Contract Medical International GmbH : blueflow Venous Stent 14th August 2025 Bare-metal peripheral venous stent MHRA reference: 36486730   2025/008/015/601/030
  10. Heraeus Medical Components-Contract Medical International GmbH : Fortress Introducer Sheath System 15th July 2025 Model: 6F Straight 45c MHRA reference: 36488569   2025/007/025/601/052
  11. KLS Martin SE ; Co. KG: RECONPLATE 26-HOLE PREFORM. LEFT T=3,0 19th August 2025 Craniofacial fixation plate, non-bioabsorbable, no MHRA reference: 36508301   2025/008/020/601/006
  12. Maquet Cardiopulmonary GmbH : see 8 Comments 12th June 2025 Trolley, medical device Model: see 8 Comments MHRA reference: 36501805   2025/006/013/601/064
  13. Olympus Medical Systems Corporation: EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE 18th October 2024 Flexible video gastroduodenoscope Model: GIF-1TH190 MHRA reference: 36507522   2025/008/001/601/007
  14. SERF: NOVAE CI E 25th June 2025 Model: CI 43/22.2 E and CI 51/22.2 E MHRA reference: 36497788   2025/008/019/601/019
  15. Siemens Healthcare Diagnostics Products GmbH : INNOVANCE VWF Ac 45809 MHRA reference: 36496667   2025/007/004/601/047
  16. Spinal Kinetics LLC : M6-C Artificial Cervical Disc 13th August 2025 MHRA reference: 36496358   2025/008/018/601/035

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 summaryChange(s) made
05/05/25 –  09/05/25 updated 21/08/25Updated to add Schiller Medical: SCHILLER 45748 Monitoring system Model: MAGLIFE RT-1 MHRA reference: 36497451   2025/004/030/601/074

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/  

Kind regards

Incident Reporting & Investigation Centre (IRIC)

NHSScotland Assure

NHS National Services Scotland

Tel: 0131 275 7575 | nss.iric@nhs.scot 

IRIC operates incident learning and prevention systems for health and care technologies (medical devices, IVDs, estates, facilities, social care equipment and PPE). Find out more in CEL43 (2009), explore our educational content on Turas Learn or visit our website to: report an incident, find our safety alerts, or watch our short Intro to IRIC video

 

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 in our NSS Strategic Framework 2024-2026

FAC406-212, 8B(i), Rev 7

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