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

FDA device recall Z-1113-2026 · posted 2026-01-16 · Open, Classified

Recall details

Recalling firm

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Reason for recall

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.

Action taken

On December 12, 2025, Philips sent URGENT Medical Device Correction letters to customers. Actions to be taken: - Circulate this Urgent Medical Device Correction letter to all users of the system so that they are aware of the issues. " In case the affected system has been transferred to another organization, please send a copy of this Urgent Medical Device Correction letter to that organization and inform Philips about this transfer through your local Philips representative. " Keep this Urgent Medical Device Correction letter with the documentation of the system until Philips corrects your system. Ensure that the letter is in a place likely to be seen/viewed. " Complete and return the response form included in this Urgent Medical Device Correction letter to Philips promptly and no later than 30 days from receipt. Completing this form confirms receipt of the Urgent Medical Device Correction letter and understanding of the issues and required actions to be taken. " If you experience an issue described in this letter, please report it to your local Philips representative. Your local Philips representative will contact you to schedule visits to install the software updates once available. ***Update May 8, 2026*** Previously, Philips planned to resolve issue 1 with software update 3.1.5 and issue 2 with software update 3.1.15. Philips has now updated their plan thusly: Both issues 1 and 2 will be included with software release 3.1.15. Anticipated release date of software version 3.1.15 has been moved to Q3 2026.

Root cause

Software design

Status

Open, Classified

Product code

OWB

Quantity affected

228 units (all OUS)

Distribution

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, P

Date initiated

2025-12-12

Date posted

2026-01-16

Location

Best, Netherlands

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