Health Canada Classifies Philips Lumify Ultrasound Recall as Type I
Health Canada has classified the recall of Philips Lumify portable ultrasound systems as Type I after software-related transducer re-registration failures and unstable USB connections were found to prevent or interrupt scanning and delay patient care.
Decision support
Decision summary
Official recall information is separated from MedTech Current editorial analysis.
Official recall information
What happened
Health Canada classified the Lumify recall as Type I. Unexpected transducer re-registration can prevent scanning until internet access is available; an unstable USB connection can also interrupt scanning and delay care.
MedTech Current analysis
Why it matters
A registration failure can leave an otherwise portable ultrasound system unavailable in an ambulance, aircraft, or field setting without network access. Pre-hospital scan interruptions and delays have been reported. Recovery depends on connectivity, while an unstable transducer connection can interrupt continuous operation.
Official recall information
Official actions
According to Health Canada:
- Contact the manufacturer if additional information is needed.
Detailed recall information
Detailed sourced information from the published Recall Brief follows.
What changed
Philips Ultrasound is recalling affected Lumify portable ultrasound systems because two issues may prevent or delay scanning. Health Canada classifies the recall as Type I under identification number RA-82731.
A software defect may stop the Lumify application from recognizing a previously registered transducer. The app can then unexpectedly require re-registration, outside the criteria in the user guide and without warning before point-of-care use. Scanning cannot resume until registration is complete, and registration requires Wi-Fi or cellular access.
This creates a particular problem outside hospitals. An ambulance, aircraft, or field team may have no network connection when the prompt appears. Philips has received reports of erroneous re-registration events that prevented pre-hospital scanning and delayed patient care in locations without network access.
The second issue concerns the USB connection between the transducer and the user’s tablet or phone. It may disconnect or become unstable during use, interrupting continuous operation and potentially delaying care.
MedTech Current analysis: Portability depends on the system being ready when care is needed. If software unexpectedly forces registration, recovery requires connectivity that may be unavailable in a pre-hospital setting. The recall brings that operational dependency, together with the unstable transducer connection, into focus for time-sensitive imaging.
Who and what are affected
Health Canada lists these affected Lumify products and model or catalogue identifiers:
| Product | Model / catalogue number |
|---|---|
| Lumify Ultrasound System | 3.0 |
| Lumify Ultrasound System | LUMIFY ULTRASOUND SYSTEM |
| Lumify Ultrasound System | 4.0 |
| Lumify Diagnostic Ultrasound System | 795005 |
| Lumify Diagnostic Ultrasound System iOS | 795161 |
| Lumify Diagnostic Ultrasound System iOS | 5.1.3 |
The notice lists lot or serial number as not applicable. The recall date is October 1, 2026; Health Canada published the Type I notice on October 5.
Official actions
Health Canada’s public notice tells healthcare users to contact Philips if they need additional information.
It does not set out recall-specific mitigation steps such as mandatory pre-departure registration checks or a requirement to carry an alternative diagnostic system. Philips’ general Lumify support page confirms that registration needs internet access and advises users to keep the transducer securely connected during registration and troubleshooting. That general guidance is separate from the recall instructions.