Field Safety Notice GE HealthCare TruSignal SpO2 Sensors (ICN 2197)

MHRA TBA

Recall Reference: 28

Alert:

• The supplier GE HealthCare has issued an urgent Field Safety Notice relating to the TruSignal SpO2 Sensors, due to three safety issues:
  • Safety Issue 1 – the sensors can potentially reduce the amount of electrical energy reaching the patient during external defibrillation
  • Safety Issue 2 – the affected sensors that have been saturated with fluids, can expose the patient to unintended voltage if the patient comes in contact with a faulty external power source while wearing the affected sensor
  • Safety Issue 3 – affected sensors may contain additional material that can block the emitter or detector areas potentially leading to an inaccurate SpO2 reading.
• Not all product codes are affected by all three safety issues. Please see table 1 on page 3 of the Field Safety Notice for specific codes and safety issue numbers.

Products Affected:

• These product codes were previously available to order through NHS Supply Chain, please see our Downloads ▼ section to refer to the product listing.
• Please note many of these products are now suspended and unavailable to order. Please see our Useful Links section to refer to ICN 2140 for updates on availability.
• GE HealthCare advise they have no short-term solution, however they are working with the manufacturer and testing to enable a longer term solution to this issue. It estimates an availability date of September/October 2023. Priority will be given to replace the products destroyed because of this Field Safety Notice.

Next Steps:

• Read and follow the full instructions and corrective actions required in this Field Safety Notice and share with all users of the affected product codes.
• Locally risk-assess options outlined in the FSN and apply appropriate local interventions to ensure continuity of safe patient care.
• Complete the Medical Device Notification Acknowledgement Response, page 6 and 7 and email to 39004@ge.com.
• On receipt of the completed Acknowledgment Response Form, GE HealthCare will contact you to arrange replacement of the affected products free of charge. The affected devices should then be destroyed in accordance with your local regulations.
• Please also contact your local NHS Supply Chain Customer Service Advisor with full details of all products destroyed. You will be given a unique CMS log number which should be quoted in the event you require our assistance.
• If you have any questions or concerns regarding this notification, please contact GE HealthCare Service or your local Service Representative. UKI Technical Support Representative. Telephone 01707 263570 or email askuktechnicalsupport@ge.com.

If you have any further questions, please contact your local NHS Supply Chain Customer Service Advisor.

Please be aware that in the event of a Field Safety Notice/Product Recall we may need to provide manufacturers, UK responsible Persons and Distributers with contact details of customers who have potentially received the affected stock. This is to help them to reconcile their stock and evidence to the regulators that all actions have been taken to ensure that the unused products have been removed from customers to prevent inadvertent use of faulty and potentially unsafe products.