Philips Azurion 5 M12 Recall Over 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 345 units of its Azurion 5 M12 medical devices due to potential failures in X-ray imaging when using 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 15, 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 certain Azurion 5 M12 systems. This voluntary recall was initiated by the firm and classified as Class II by the FDA.
Which Products Are Affected
The affected products are Azurion 5 M12 systems with the following details: System Code (1) 722227, UDI: 00884838099227; and System Code (2) 722231, UDI: 00884838099258. A total of 345 units are involved, with 10 units in the US and 335 outside the US. The systems have various serial numbers as listed in the recall notice. Distribution includes nationwide in the US and internationally to countries such as Afghanistan, Albania, and others. The recall number is Z-1679-2026.
What You Should Do
Affected users should follow the initial firm notification, which was sent via letter, for instructions on the recall. Contact Philips Medical Systems Nederland B.V. for details on returns, refunds, or further actions related to the affected devices.
Why This Matters
This recall addresses potential malfunctions in medical imaging devices that could impact diagnostic procedures, highlighting the importance of reliable equipment in healthcare to ensure patient safety without posing immediate life-threatening risks.
Source
FDA recall notice Z-1679-2026
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 (1,363 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to April 15, 2026.
Frequently Asked Questions
Common questions about this FDA recall.