Philips Azurion System with software versions: R2.2.O, R2.2.1, R2.2.3, R2.2.5 and R2.2.6. Models/Model Number: (1) Azurion 3M12: 722063, 722221; (2) Azurion 3M15: 722064, 722222; (3) Azurion SM12: 722227; (4) Azurion SM20: 722228; (5) Azurion 7B12/12: 722067, 722225; (6) Azurion 7820/15: 722068, 722226; (7) Azurion 7M12: 722078, 722223; (8) Azurion 7M20 : 722079, 722224

Recall Insight

This FDA Devices action (record #Z-1647-2023) was formally reported on June 7, 2023, with the manufacturer initiating the action on March 21, 2023. It is classified under Moderate severity (Class II), with a current status of Ongoing. PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. is listed as the recalling firm, operating out of Best, N/A. Federal records indicate USA: 1063 R.O.W. 2136 units are affected, placing this recall in the million-unit bracket that typically triggers nationwide consumer alerts and retailer sweeps.

The documented reason for this recall is: Potential Loss of X-ray-When the full disk capacity is reached, X-Ray functionality will cease to be available there will be a sudden interruption of the procedure Distribution data in the federal record shows the product reached: Nationwide Foreign: Algeria Argentina Armenia Australia Austria Bahrain Bangladesh Belarus Belgium Bolivia Brazil Bulgaria Cambodia Chile China Colombia Costa Rica C¿te D'Ivoire Croatia Cyprus Czech Republic Denmark Do…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 3 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.