Philips Azurion 3M15, Model Numbers: 722064, 722222 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with

FDA device recall Z-2285-2026 · posted 2026-06-01 · Open, Classified

Recall details

Recalling firm: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Reason for recall: During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. The dark image may result after the user performs a pedal tap (shortly touching the footswitch pedal without generating an Xray image). The pedal tap may cause a dark image with the next fluoroscopy run.
Action taken: Philips issued an IMPORTANT PRODUCT NOTICE to its consignees on 12/7/2023 via USPS mail. The notice explained the problem with the device and the circumstances under which if could occur and actions to be taken to minimize the effect of the problem. The notice further instructed the user to: - Keep this Important Product Notice with the documentation of the system until Philips corrects your system. - Circulate this notice to all users of the system so that they are aware of the issue. - Return the attached reply form to Philips to confirm that the users of the system have reviewed and understood this Important Product Notice. For further information or support concerning this issue, please contact your local Philips representative: Technical Support Line: 1-800-722-9377.
Root cause: Software design
Status: Open, Classified
Product code: OWB
Quantity affected: 27 units
Distribution: US Nationwide distribution.
Date initiated: 2023-12-07
Date posted: 2026-06-01
Location: Best, Netherlands

Recalls and clearances share one API, with change alerts when new recalls post.

Record	Firm	Date
Azurion R2.1 (K200917)	Philips Medical Systems Nederland B.V.	2020-05-01
Azurion R2.0 (K181830)	Philips Medical Systems Nederland B.V.	2018-08-02
Azurion series R1.2 (K172822)	Philips Medical Systems Nederland B.V.	2017-11-22