Philips Lumify Diagnostic Ultrasound System Recalled for Connection Issues
Philips is recalling 13,206 Lumify Diagnostic Ultrasound Systems due to software and connection issues that may prevent scanning or disrupt function, potentially delaying diagnosis or treatment.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class I, and the source text states that the issues may cause diagnosis or treatment delay. The source does not report any illnesses, injuries, or deaths.
Plain-English summary
Philips Ultrasound, LLC is recalling 13,206 units of the Philips Lumify Diagnostic Ultrasound System. The recall is due to software and hardware issues that may prevent the system from recognizing a previously registered transducer or cause unstable connections between the transducer and the tablet or phone. These issues may require re-registration using Wi-Fi or cellular access, which may be unavailable in field settings such as ambulances or aircraft, and may disrupt scanning functions.
The affected products are distributed worldwide, including nationwide in the United States and in numerous other countries. The recall covers specific software versions for Android and iOS devices. The source text does not report any illnesses, injuries, or deaths associated with this recall.
Consumers and healthcare providers should stop using the affected systems and contact Philips Ultrasound, LLC for instructions on how to resolve the issues or obtain a replacement.
The recalled product
- Product
- Philips Lumify Diagnostic Ultrasound System
- Manufacturer
- Philips Ultrasound, LLC
- Affected units
- 13,206
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- UDI-DI/Software Version: Android: 00884838122116/1.X
- 3.X
- 4.X
- 5.X. iOS: 00884838124141/2.X and 5.X
Distribution
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