Allura Xper FD20/15; Model Numbers: 722058; Associated 510(k)s: K102005, K130638, K130842, K133292
Pending LLM rewrite. Source: FDA_DEVICE Z-0010-2026.
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
The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. No user messages are shown before the battery is low on power or depleted.
The recalled product
- Product
- Allura Xper FD20/15; Model Numbers: 722058; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
- 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)
- Model Numbers: 722058
- UDI-DI: 00884838059115
- Serial Numbers: 337
- 178
- 249
- 22
- 202
- 279
- 254
- 285
- 71
- 186
- 82
- 85
- 162
- 138
- 24
- 365
- 203
- 167
Distribution
Distributed nationwide across the United States.
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