Philips Azurion 7 B12 Recall for X-ray Imaging Issues
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Philips Medical Systems is recalling 670 units of Azurion 7 B12 medical devices due to potential failures in X-ray imaging initiation when using the wired foot switch.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on April 16, 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.
Philips Azurion 7 B12 Recall
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 affected devices.
Which Products Are Affected
The affected products are Azurion 7 B12 medical devices with the following system codes: (1) 722067, (2) 722225, and (3) 722235. The recall involves 670 units total, with 106 units in the US and 564 units outside the US. Specific UDIs are: (1) 00884838085350, (2) 00884838099265, and (3) 00884838116788. The recall number is Z-1675-2026, and distribution was nationwide in the US as well as in various international countries.
What You Should Do
Consumers should follow the initial firm notification, which was sent via letter, and contact the recalling firm, Philips Medical Systems Nederland B.V., for further instructions on the voluntary recall.
Why This Matters
This recall affects medical devices used in healthcare settings, potentially impacting the reliability of X-ray imaging and patient safety in the US and internationally.
Source
FDA recall notice Z-1675-2026
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 (1,126 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to April 16, 2026.
Frequently Asked Questions
Common questions about this FDA recall.