Field Safety Notice Masimo LNCS Disposable Sensors FBC119 (ICN 2570)

Alert:

• Masimo has issued a Field Safety Notice having ascertained certain parts and Lot numbers of LNCS Disposable Sensors manufactured between March 2024 and the end of May 2024 are not compatible with older versions of Masimo technology boards used in both Masimo monitors and OEM monitors.
• The affected sensors cannot be authenticated by certain older versions of Masimo technology boards, preventing their use, whereas use on newer versions of Masimo technology boards is not affected.
• Masimo advise there are no health consequences associated with this issue. The issue may render affected sensors unusable when connected to older versions of Masimo technology boards.

Products Affected:

• The affected product is available from NHS Supply Chain eDirect route:

• Masimo confirm the issue has been addressed and currently manufactured sensors are not affected.

Next Steps:

• Read and follow the full instructions in the Field Safety Notice and share with all users of the affected products.
• If the affected LNCS Disposable Sensors are connected to newer versions of Masimo technology boards and provide SpO2 and pulse rate values, they can be used as labelled.
• If the affected LNCS Disposable Sensors are connected to older versions of Masimo technology boards and do not provide readings or result in an error message such as ’Replace Sensor’, please place the sensor(s) aside and follow the steps defined in the ‘Actions to be taken by Customer’ section of the Field Safety Notice.
• Assess your inventory to identify if you have affected LNCS Disposable Sensors which are not able to provide SpO2 and pulse rate values listed in Attachment 2 – Part number and Lot number; then contact Masimo Technical Services to request return of the affected part and Lot number for replacement – http://service.masimo.com

If you have any further questions, please contact your local NHS Supply Chain Customer Service Advisor or the Hospital Care Team.

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.