Azurion 3 M12; Catalog numbers: (1) 722063, (2) 722221.

Recall Insight

This FDA Devices action (record #Z-1153-2025) was formally reported on February 26, 2025, with the manufacturer initiating the action on January 13, 2025. It is classified under Critical severity (Class I), 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 263 units (26 US, 237 OUS) 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: Possibility of the patient falling from the table related to the mattress used on the patient table. Distribution data in the federal record shows the product reached: Worldiwde distribution - US Nationwide and the countries of Afghanistan, Albania, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Braz…. 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 1 year 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.