Agency classClass IIOur severity:High FDA (Devices)·Z-2627-2025·Announced 2025-10-01

Allura Xper FD20 Biplane recalled over component deterioration affecting motorized movements

Philips Allura Xper FD20 Biplane systems are recalled because deterioration of the CMOS battery, hard disk drive and/or power supply may make motorized movements unavailable. 268 units are affected.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Rubric level 3 covers risk-of-harm products where injury has not yet been reported; loss of motorized movement during an interventional procedure is a potential harm and no injuries are reported.

Plain-English summary

The Philips Allura Xper FD20 Biplane is being recalled under product codes 722013 and 722008, with UDI-DI 00884838059061 and the serial numbers listed in the recall notice. The recall covers 268 units, of which 102 are in the United States and 166 outside it.

Systems may not perform as intended because of deterioration of certain internal components: the CMOS battery, hard disk drive and/or power supply unit. If this deterioration occurs, motorized movements of the system become unavailable, leaving only manual movements of the stand and table. The FDA classified the action as Class II.

Imaging sites operating these systems should follow the manufacturer's instructions for inspection and correction.

The recalled product

Product: Allura Xper FD20 Biplane Product Codes: (1)722013, (2) 722008; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
Manufacturer: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Category: Medical Device — Imaging System
Hazard: component-deterioration
motorized-movement
interventional-imaging
class-ii

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)

Product Codes: (1)722013
(2) 722008
UDI-DI: (1) 00884838059061
(2) N/A
Serial numbers: (1) 505
313
34
153
410
360
290
241
404
126
244
106
346
383
461
307

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 13 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 13 products in this recall →

Same manufacturer · PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

See all →

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Same hazard · component deterioration