Philips Allura X-Ray System Recall

Source: FDA · United States

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 257 units of the Allura Centron interventional fluoroscopic X-ray system 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 19, 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 the Philips Allura, Cardio Vascular-Allura Centron Interventional Fluoroscopic X-Ray System due to potential loss of imaging functionality, loss of motorized movement, or loss of data caused by unauthorized Hard Disk Drives.

Which Products Are Affected

The recall affects the Philips Allura, Cardio Vascular-Allura Centron with Model Number 722400. A total of 257 units are involved. The devices were distributed nationwide in the United States. The recall number is Z-2893-2026. Multiple UDI numbers are associated with the affected units.

What You Should Do

Users should follow guidance from the recalling firm regarding the potential issues with imaging functionality, motorized movement, or data loss.

Why This Matters

The Class II recall addresses a defect that could lead to temporary or reversible health consequences from loss of system functionality during use.

Source

FDA recall number Z-2893-2026, report date 20260812.

Original source: FDA Official Notice ↗

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.

Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
Philips Medical Systems Nederland B.V. is recalling 257 units of the Allura Centron interventional fluoroscopic X-ray system due to potential loss of imaging functionality from unauthorized hard disk drives.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "medium" severity. Stay informed and follow agency guidance.
What area is affected?
This alert affects United States. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.