Recall of Philips ALLURA Xper FD10/10 Medical Devices
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 certain ALLURA Xper FD10/10 systems 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 FD10/10 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 systems.
Which Products Are Affected
The affected products are the ALLURA Xper FD10/10 systems with the following system codes: (1) 722005, (2) 722011, and (3) 722027. Specific serial numbers are listed in the recall notice, including for system code 722005: numbers such as 321, 285, and others up to 519; for 722011: numbers like 49, 137, and up to 292; for 722027: numbers like 351, 332, and up to 330. The recall involves 112 units total, with 138 units distributed in the US and 422 outside the US. Distribution is nationwide in the US and includes international countries such as Afghanistan, Australia, and others as specified.
What You Should Do
Consumers and healthcare providers should follow the firm's initial notification, which was issued via letter, and contact PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. for further instructions on the recall, including returns or refunds.
Why This Matters
This recall highlights potential risks in medical imaging devices that could affect diagnostic accuracy, emphasizing the importance of device reliability in healthcare settings.
Source
FDA Recall Notice: Z-1662-2026, attributed to the FDA database.
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 (1,384 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.