[pending] Lumify Diagnostic Ultrasound System models : 795005, 795161, 989605449841,
Pending LLM rewrite. Source: FDA_DEVICE Z-0883-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
Ultrasound system compatibility issues with Apple devices running iOS 18 may cause a failure to perform live imagining.
The recalled product
- Product
- Lumify Diagnostic Ultrasound System models : 795005, 795161, 989605449841,
- Manufacturer
- Philips Ultrasound, LLC
- Category
- Medical Device — Devices
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 (3)
- UDI:700884838103405
- 00884838120266
- 00884838064713
Distribution
Distributed nationwide across the United States.
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