Philips Azurion 3 M12 Recall for X-ray Imaging Issues
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
Philips is recalling 298 units of the Azurion 3 M12 medical device due to potential failures in initiating X-ray imaging with the wired foot switch, affecting systems distributed nationwide in the US.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on April 14, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Devices.
What Happened
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch on the Azurion 3 M12 systems, leading to a voluntary recall classified as Class II by the FDA.
Which Products Are Affected
The affected products are Azurion 3 M12 systems with the following System Codes: (1) 722063, (2) 722221, and (3) 722229. The Universal Device Identifier (UDI) for these systems is 00884838085275. A total of 298 units are involved, with 27 units in the US and 271 units outside the US. Specific serial numbers are associated with each system code, and distribution includes nationwide in the US as well as international locations. The recall number is Z-1673-2026.
What You Should Do
Consumers should follow the initial firm notification, which was issued via letter, and contact the recalling firm, PHILIPS MEDICAL SYSTEMS NEDERLAND B.V., located at Veenpluis 6, Best, Netherlands, for instructions on the recall.
Why This Matters
This recall addresses a potential malfunction in critical medical imaging equipment, which could impact diagnostic procedures and patient care, highlighting the importance of device reliability in healthcare settings.
Source
FDA recall notice for event ID 98434, available at the FDA website under recall number Z-1673-2026.
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,341 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to April 14, 2026.
Frequently Asked Questions
Common questions about this FDA recall.