Philips Azurion 7 M12 Recall Due to X-ray Imaging Issues
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Philips is recalling 1994 units of Azurion 7 M12 medical devices due to potential failures in X-ray imaging initiation 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.
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Philips Azurion 7 M12 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 recall involves the Azurion 7 M12 medical devices with the following system codes: (1) 722078 with UDI 00884838085251, (2) 722223 with UDI 00884838099241, and (3) 722233 with UDI 00884838116764. A total of 1994 units are affected, including 360 units in the US and 1634 units outside the US. The recall number is Z-1677-2026, and it was initiated on March 3, 2026.
What You Should Do
Consumers should contact Philips Medical Systems Nederland B.V. for further instructions, as the initial notification was made via letter. No specific contact information is provided in the source data.
Why This Matters
This recall addresses potential malfunctions in medical imaging devices that could affect diagnostic procedures, potentially leading to risks in patient care although the impact is not specified as immediately life-threatening.
Source
Attribution: FDA. For more information, visit the FDA website and search for recall number Z-1677-2026.
Original source: FDA Official Notice ↗
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