Philips Azurion Systems with software versions R2.1.10 and R2.2.10. Includes the following label descriptions and corres

FDA device recall Z-1091-2026 · posted 2026-01-14 · Open, Classified

Recall details

Recalling firm

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Reason for recall

Six (6) identified software issues which may result in the following: system keeps restarting, AMC triple drive, C-Partition of Suite PC running out of free space, system remains in continuous restart mode after the start-up, misalignment of Market Tool Overlay, and longitudinal positional error.

Action taken

Philips notified consignees on about 12/12/2025 via certified mailing. Consignees were instructed to identify any affected systems on hand, circulate the noification to all users of the system for awareness, notify any recipients if the affected systems have been transferred to another organization, maintain the notification with documentation of the system until Philips completes the correction, and complete and return the response form provided. Philips also provided recommended actions for each issue, if encountered. Philips will address the identified issues by implementing a software update (R2.1.15 or R2.2.15) in all affected systems (FCO72200660 to 2.2.15, FCO72200672 to 2.1.15). Philips expects to have this software update released by Q4 2026 (subject to regulatory clearance). Local Philips representatives will contact each consignee to schedule a visit to install the software updates once available.

Root cause

Software design

Status

Open, Classified

Product code

OWB

Quantity affected

10,466 units

Distribution

Worldwide distribution - US Nationwide and the countries of Afghanistan, Albania, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia an

Date initiated

2025-12-12

Date posted

2026-01-14

Location

Best, Netherlands

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