Allura Xper FD10/10; Model Numbers: (1) 722005, (2) 722011, (3) 722027; Associated 510(k)s: K10200
Pending LLM rewrite. Source: FDA_DEVICE Z-0003-2026.
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 FD10/10; Model Numbers: (1) 722005, (2) 722011, (3) 722027; 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: (1) 722005
- (2) 722011
- (3) 722027
- UDI-DI: (1) N/A
- (2) 00884838059047
- (3) 00884838054196
- Serial Numbers: (1) 361
- 212
- 233
- 321
- 435
- 285
- 384
- 388
- 343
- 399
- 392
- 128
- 355
- 51
Distribution
Distributed nationwide across the United States.
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