The Recall Desk
ModerateFDA (Devices)·Z-0002-2026·Announced 2025-10-08

Allura Xper FD10 X-ray systems recalled over premature BIOS battery depletion

Philips is recalling 2,317 Allura Xper FD10 interventional X-ray systems because the BIOS battery may deplete faster than designed, halting start-up with no warning.

What this means for you

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 FD10 interventional X-ray systems, model numbers 722003, 722010 and 722026, 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 2,317 units, of which 497 are in the United States and 1,820 outside it, 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 FD10; Model Numbers: (1) 722003, (2) 722010, (3) 722026; 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

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) 722003
  • (2) 722010
  • (3) 722026
  • UDI-DI: (1) N/A
  • (2) 00884838059030
  • (3) 00884838054189
  • Serial Numbers: (1) 1343
  • 1349
  • 1153
  • 1154
  • 1472
  • 257
  • 1694
  • 746
  • 745
  • 1599
  • 501
  • 503
  • 1360
  • 959

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 →

Related recalls

Same manufacturer · PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

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Same hazard · battery depletion

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