The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0001-2026·Announced 2025-10-08

Allura Xper FD10C X-ray systems recalled over premature BIOS battery depletion

Philips is recalling Allura Xper FD10C interventional X-ray systems because the BIOS battery may deplete faster than designed, halting system start-up with no prior warning.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: Scored 2 as a component failure whose stated effect is that the system will not start; the notice describes no in-use hazard or patient harm.

Plain-English summary

Allura Xper FD10C interventional X-ray systems, model number 722001, are being recalled because the BIOS battery may deplete faster than was anticipated during the design phase.

When the battery is depleted, the start-up process of the system is halted and the system will not start. No user messages are shown before the battery is low on power or depleted, so there is no advance indication that the failure is coming.

The recall covers 2 units in the United States, with serial numbers 19 and 21, from a worldwide distribution. The FDA has classified the action as Class II.

Affected sites should follow Philips' instructions for battery replacement and plan for the possibility that a system may not start when next powered on.

The recalled product

Product
Allura Xper FD10C; Model Number: 722001; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Manufacturer
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Category
Medical Device — Interventional X-ray
Hazard
Affected units
2

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 (4)

  • Model Number: 722003
  • UDI-DI: N/A
  • Serial Numbers: 19
  • 21

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 15 recalled by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 15 products in this recall →

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