[mdr] Philips Lumify Topical Transducer

Recalling firm
Philips New Zealand Commercial Limited
Product
[MDR] Philips Lumify Topical Transducer. [Device]. Model: Lumify Diagnostic Ultrasound System; Lumify Diagnostic Ultrasound System. Affected: All Software is impacted: Android Software versions: 1.X, 3.X, 4.X, 5.X iOS Software Versions: 2.X and 5.X; All Software is impacted: Android Software versions: 1.X, 3.X, 4.X, 5.X iOS Software Versions: 2.X and 5.X. Also covers: [MDR]Philips Lumify Ultrasound Systems
Reason
The manufacturer has identified the following potential problems with the Lumify Diagnostic Ultrasound System which may prevent or delay scanning functionality:, 1. Due to a software problem, the Lumify application may incorrectly require a previously registered transducer to be re-registered before use. Scanning cannot proceed until registration is completed, which requires Wi-Fi or cellular connectivity. In environments without network access, such as ambulances, aircraft, or remote settings, this may delay patient care., 2. The connection between the Lumify transducer USB cable and the...
Classification
Class I
Category
medical device recall
Country
New Zealand
Agency
MEDSAFE
Recall date
2026-10-19
Status
Ongoing
Distribution
New Zealand - Hospital/Pharmacy/Laboratory

Official recall notice from MEDSAFE

Recall details on Nibble Recalls: https://trynibble.app/recalls/379fe338-a848-450f-843c-4e48c662640c