The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0006-2026·Announced 2025-10-08

Allura Xper FD20 Biplane systems recalled over premature BIOS battery depletion

Philips is recalling 501 Allura Xper FD20 Biplane interventional X-ray systems because the BIOS battery may deplete faster than designed, halting start-up.

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 FD20 Biplane interventional X-ray systems, model numbers 722008 and 722013, 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.

The recall covers 501 units, of which 212 are in the United States and 289 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 of a system failing to start without prior warning.

The recalled product

Product
Allura Xper FD20 Biplane; Model Numbers: (1) 722008, (2) 722013; 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) 722008
  • (2) 722013
  • UDI-DI: (1) N/A
  • (2) 00884838059061
  • Serial Numbers: (1) 491
  • 489
  • 360
  • 325
  • 142
  • 125
  • 312
  • 319
  • 82
  • 192
  • 244
  • 453
  • 306
  • 116
  • 124
  • 18270

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.

See all →

Same hazard · battery depletion

See all →

Similar recalls