Philips Allura Xper Systems 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 Medical Systems Nederland B.V. is recalling 5,012 units of Allura Xper interventional fluoroscopic X-ray systems due to potential loss of imaging functionality from unauthorized hard disk drives.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on August 20, 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, medical-devices.
What Happened
Philips Medical Systems Nederland B.V. initiated a voluntary recall of certain Allura Xper systems after identifying a risk of potential loss of imaging functionality, loss of motorized movement, or loss of data due to unauthorized Hard Disk Drives.
Which Products Are Affected
The recall covers Philips Allura interventional fluoroscopic X-ray systems under multiple system descriptions and model numbers including: Allura Xper FD10 (722003, 722010, 722026); Allura Xper FD10 OR Table (722033); Allura Xper FD10/10 (722005, 722011, 722027); Allura Xper FD10C (722001); Allura Xper FD20 (722006, 722012, 722028); Allura Xper FD20 Biplane (722008, 722013); Allura Xper FD20 Biplane OR Table (722025); Allura Xper FD20 OR Table (722015, 722023, 722035); Allura Xper FD20/10 (722029); Allura Xper FD20/15 (722058); Allura Xper FD20/15 OR Table (722059); Allura Xper FD20/20 (722038); Allura Xper FD20/20 OR Table (722039); Allura Xper R9 7 M12 (722065); and Allura Xper R9 7 M20 (722066). A total of 5,012 units are affected and were distributed nationwide in the United States. The recall number is Z-2891-2026. The recall is classified as Class II and remains ongoing.
What You Should Do
No specific consumer action steps or contact information for returns or refunds are provided in the recall notice.
Why This Matters
The recall involves medical imaging devices used in interventional procedures, with the potential for loss of critical functionality affecting 5,012 units distributed across the United States.
Source
FDA recall number Z-2891-2026. Data from FDA enforcement report.
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 (1,616 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to August 20, 2026.
Frequently Asked Questions
Common questions about this FDA recall.