[pending] Philips DXR System, DuraDiagnost Rel. 4. Stationary X-Ray System.
Pending LLM rewrite. Source: FDA_DEVICE Z-1554-2025.
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
Potential for collimator to fall as a result of incorrect installation.
The recalled product
- Product
- Philips DXR System, DuraDiagnost Rel. 4. Stationary X-Ray System.
- Manufacturer
- Philips North America 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 (11)
- REF 712214
- UDI: (01)00884838064751(21)
- Serial No. SN170009
- SN170010
- SN180072
- SN180020 200037
- SN160061
- SN180075
- 200089
- SN180045
- SN160096.
Distribution
Distributed nationwide across the United States.
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