Philips Azurion X-Ray Systems Recall for Hard Drive Issue
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 3,341 Azurion 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 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 certain Azurion 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 Azurion under the following System Descriptions and model numbers:
- Azurion 3 M12: Model Numbers 722063, 722221
- Azurion 3 M15: Model Numbers 722064, 722222, 722280
- Azurion 5 M12: Model Number 722227
- Azurion 5 M20: Model Numbers 722228, 722281
- Azurion 7 B12: Model Numbers 722067, 722225
- Azurion 7 B20: Model Numbers 722068, 722226
- Azurion 7 M12: Model Numbers 722078, 722223
- Azurion 7 M20: Model Numbers 722079, 722224, 722282
A total of 3,341 units are affected. The products were distributed nationwide in the United States. The recall number is Z-2892-2026. Full UDI and serial information is available in the FDA record.
What You Should Do
The recalling firm notified customers by letter. Consumers with affected systems should follow instructions provided in the notification from Philips Medical Systems Nederland B.V.
Why This Matters
The Class II recall addresses a defect that could result in loss of critical imaging or movement functions during interventional procedures.
Source
FDA recall Z-2892-2026, report date 20260812. Agency: FDA. Recalling firm: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
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 (1,457 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to August 19, 2026.
Frequently Asked Questions
Common questions about this FDA recall.