FDA-Device2026-01-28Class IIPROCESSING DEFECT

Philips Azurion X-ray system software recall for imaging loss and motorized movement failure

OTHERAR AZ CO DE ID IL IN MA MO Medical devices

What this means

Philips has identified two software issues in Azurion R3.1 systems that may cause the device to restart continuously, lose X-ray imaging capability, lose motorized movement, display incorrect images, or lose data. One issue affects all models; a second affects only systems with a Poly-G3 frontal stand.

Check if your Azurion system model and serial number match the recall list
Contact Philips Medical Systems immediately if your system is affected
Do not use an affected system until Philips provides a software update or resolution

The agency's original wording

Hazard

Philips has identified two (2) software issues affecting device systems that may result in loss of imaging (X-ray) functionality and/or loss of motorized movement, and/or incorrect image content and/or loss of data. Issue 1 - System remains in continuous restart mode after the start-up. Issue 2 - Longitudinal Position Error Applicable only to systems with Poly-G3 frontal stand.

Intended for

Adults

Illnesses reported

None reported

Sold states

International distribution in the countries of AE, AR, AT, AZ, BE, BG, BH, BR, BS, CH, CL, CO, CR, CY, CZ, DE, DK, DZ, EC, EG, ES, GB, GR, GT, ID, IE, IL, IN, IQ, IT, JE, JP, LB, MA, MO, NI, NL, NO, PE, PL, RO, SA, SE, SV, TR, UA, VE, VN, ZA;

Affected count

228 units (all OUS)

Manufactured in

Veenpluis 4-6, Best, Netherlands

Products

Philips Azurion system; Software Version Number: R3.1;

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1113-2026

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