Philips Azurion Recall Due to Software Issues
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 10,872 Azurion interventional fluoroscopic X-ray systems worldwide due to two software-related issues.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on August 26, 2026 and geographically references Worldwide. 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
The recall addresses two software issues in Azurion R2.2.10 systems that may cause image quality degradation, potentially leading to delay of therapy, procedural complications, and/or inappropriate treatment, and potential loss of geometry movements, potentially leading to delay of therapy and procedural complications.
Which Products Are Affected
Philips Azurion Rystem, Model Numbers: 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222, 722223, 722224, 722225, 722226, 722227, 722228, 722280*, 722281*, and 722282* (These models are distributed only in China), with Software Version Number R2.2.10 and R2.1.10 (*This software version is distributed only in China); Interventional Fluoroscopic X-Ray System. A total of 10,872 units are affected. Distribution is worldwide. Recall number Z-2931-2026. UDI examples include (01)00884838099258(21)1229 and many others listed in FDA records.
What You Should Do
The recall is voluntary and firm-initiated via letter notification. No specific consumer action steps are detailed in the recall announcement.
Why This Matters
Class II recall of over 10,000 medical imaging systems worldwide due to software defects that could impact therapy delivery and procedural safety.
Source
FDA recall number Z-2931-2026, event ID 99422. Classification: Class II. Report date: 20260819.
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 (1,369 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to August 26, 2026.
Frequently Asked Questions
Common questions about this FDA recall.