Recall of Philips Allura Xper FD10C Systems
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
Philips Medical Systems is recalling 15 units of Allura Xper FD10C medical devices due to potential issues with X-ray imaging not initiating properly 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.
Recall of Philips Allura Xper FD10C Systems
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 Allura Xper FD10C systems with System Code: 722001. A total of 15 units are involved, with 7 units in the United States and 8 units outside the United States. The recall number is Z-1659-2026, and distribution includes nationwide in the United States as well as various international countries such as Afghanistan, Albania, and others as listed in the recall notice.
What You Should Do
Consumers and users should contact the recalling firm, Philips Medical Systems Nederland B.V., as the initial notification was made via letter. Follow the instructions provided in that notification for any necessary actions regarding the affected devices.
Why This Matters
This recall involves medical devices used in healthcare settings, which could affect diagnostic procedures if the issue occurs, potentially impacting patient care in the United States and internationally.
Source
FDA recall notice Z-1659-2026, attributed to the U.S. Food and Drug Administration.
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 (1,248 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.