The Recall Desk
ModerateFDA (Devices)·Z-0005-2026·Announced 2025-10-08

Allura Xper FD20 X-ray systems recalled over premature BIOS battery depletion

Philips is recalling 5,067 Allura Xper FD20 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 FD20 interventional X-ray systems, model numbers 722006, 722012 and 722028, 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 5,067 units, of which 1,626 are in the United States and 3,441 outside it. Distribution was worldwide. 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 FD20; Model Numbers: (1) 722006, (2) 722012, (3) 722028; 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) 722006
  • (2) 722012
  • (3) 722028
  • UDI-DI: (1) N/A
  • (2) 00884838059054
  • (3) 00884838054202
  • Serial Numbers: (1) 535
  • 2522
  • 1364
  • 2268
  • 172
  • 415
  • 2324
  • 1637
  • 2533
  • 1881
  • 2158
  • 1774
  • 468
  • 1477

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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