Health Canada5 Oct 2026
Lumify Ultrasound System
Health Canada published a recall notice for Lumify Ultrasound System on 5 Oct 2026. It is one of 311 notices of this kind from Health Canada since 2 Apr 2026 in AreaZine's record.
Recall
The recall notice
- Issued by
- Health Canada
- Issued
- 5 Oct 2026
- Recall type
- Health product recall
- Companies
- Philips Ultrasound Llc · 22100 Bothell Everett Highway, Bothell, Washington, United States, 98021
- Official source
- Health Canada: the notice at its source
The latest from Health CanadaEvery warning and recall in Canada
Source: Health Canada: the notice at its source. AreaZine rebuilds this page from the agency's record; the agency's page is the one to act on. Contains information licensed under the Open Government Licence – Canada.
The notice as issued
Issue: Potential issues with the Lumify Diagnostic Ultrasound System which may prevent or delay scanning functionality: Due to a software issue, the Lumify application may not recognize 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.Lumify devices used outside the hospital, such as in ambulances, aircraft, or field settings, are at greater risk due to reduced access to wi-fi/cellular. Philips has received reports that these erroneous re-registration events have prevented scanning in pre-hospital environments and delayed care to patients. These pre-hospital events occurred outside of wi-fi or cellular 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. Additional information Details Original published date: 2026-10-05 Affected products: Affected products Lot or serial number Model or catalogue number Lumify Ultrasound System Not applicable. 3.0 Lumify Ultrasound System Not applicable. LUMIFY ULTRASOUND SYSTEM Lumify Ultrasound System Not applicable. 4.0 Lumify Diagnostic Ultrasound System Not applicable. 795005 Lumify Diagnostic Ultrasound System iOS Not applicable. 795161 Lumify Diagnostic Ultrasound System iOS Not applicable. 5.1.3 Issue
Source: Health Canada: the notice at its source. The text is the agency's, unedited. Contains information licensed under the Open Government Licence – Canada.