Philips Azurion 5 M20 Device Recall
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 920 units of Azurion 5 M20 medical devices due to potential issues with X-ray imaging initiation using the wired foot switch.
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.
Which Products Are Affected
The affected products are Azurion 5 M20 with System Codes: (1) 722228, (2) 722232, and (3) 722281 (OUS only). The product quantity is 920 units, with 168 in the US and 752 outside the US. UDIs are: (1) 00884838099234, (2) 00884838116757, and (3) 00884838110564. Distribution includes nationwide in the US and various international countries.
What You Should Do
Consumers should contact the recalling firm, PHILIPS MEDICAL SYSTEMS NEDERLAND B.V., at Veenpluis 6, Best, Netherlands, as the recall was initiated via letter.
Why This Matters
This recall involves medical devices that could affect X-ray imaging reliability, potentially impacting diagnostic procedures in healthcare settings.
Source
FDA Recall Number: Z-1680-2026. Attribution: FDA website.
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 (949 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.