Field Safety Notice Philips Lumify Diagnostic Ultrasound System (ICN 3499)

NHSSC: 70

Alert:

• Philips has issued a Field Safety Notice due to becoming aware of an issue that potentially impacts the Lumify Ultrasound System functionality at the point of use in clinical care.
• Due to a software issue, the Lumify application may not recognise a previously registered transducer and prompt for re-registration (outside of the defined criteria in the User Guide) without warning prior to point of care use. Scanning functionality is prevented until the registration step has been completed; registration requires Wi-Fi or cellular signal access.
• Additionally, Philips has identified that the connection between the Lumify transducer USB cable to a customer’s tablet/phone may disconnect or have an unstable connection during use which may disrupt continuous function of the device and result in a delay of care.
• Loss of functionality or system failure during a procedure may result in a delay in diagnosis and/or treatment.
• Depending on the clinical situation and patient condition, delays in diagnosis or treatment could lead to serious injury or death in the most severe cases.

Products Affected:

• The affected products are available through our direct framework contracts and are not visible in our online catalogue:

Next Steps:

• Read and follow the full instructions in the Field Safety Notice and share with all users of the affected products.
• Philips advises customers/users to take the following actions to reduce risks for patients until a software update is available and installed:
  • Do not use the Lumify system outside of areas with readily accessible Wi-Fi/cellular (e.g. pre-hospital transport (ambulance, helicopter) or use outside of a traditional healthcare setting (care in the field).
  • Always have backup ultrasound devices and/or modalities available for care as advised in the User Guide.
  • Circulate this notice to all users of the device so that they are aware of the product issue and associated hazard/harm.
  • Post this notice near the affected unit(s) for ease of reference.
  • Forward this notice to any area/facility that may have the device.
• Philips is developing a software update to address the identified registration issue. Philips will communicate once the software update is available and provide instructions on any actions required.
• Additionally, Philips is working diligently to fully assess the unstable cable connection issue and identify the appropriate solution.
• For all queries or questions please contact your local Philips representative:
  • Tel +448000260086
  • Email: UKFCO@philips.com
• We are working with Philips and will provide further information to this ICN as it becomes available.