Philips Allura System configured with a 1 Phase UPS. Allura family (R1.x, R2.x). Labeled as the
Pending LLM rewrite. Source: FDA_DEVICE Z-2503-2025.
Severity not yet assessed
We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.
Plain-English summary
Philips Azurion and Allura systems configured with a 1 Phase Uninterruptible Power Supply (UPS) have the potential of shutting down and/or not starting up, if power to the system is lost.
The recalled product
- Product
- Philips Allura System configured with a 1 Phase UPS. Allura family (R1.x, R2.x). Labeled as the following with corresponding model numbers: 1. Allura Xper FD10, Model Number 722003 2. Allura Xper FD10/10, Model Number 722005 3. Allura Xper FD20, Model Number 722006
- Manufacturer
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- 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 (20)
- 1. Model Number/System Code (UDI)
- Serial Numbers: 722003 (No UDI)
- 1225
- 789
- 1138
- 445
- 740
- 152
- 1411. 2. Model Number/System Code (UDI)
- Serial Numbers: 722005 (No UDI)
- 35. 3. Model Number/System Code (UDI)
- Serial Numbers: 722006 (No UDI)
- 168
- 2198
- 2184
- 2606
- 195
- 161
- 1956
- 2256
Distribution
Distributed nationwide across the United States.
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