Recall Record: Class II Recall: Philips Azurion Systems with software versions R2.1.10 and… by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Key facts

What consumers should do

Facilities, clinicians, and consumers holding an affected unit or lot of Philips Azurion Systems with software versions R2.1.10 and R2.2.10. Includes the following label descriptions and corresponding models: 1. Azurion 3 M12. Model Numbers: 722063, 722221. 2. Azurion 3 M15. Model Numbers: 722064, 722222, 722280. 3. Azurion 5 M12. Model Number: 722227. 4. Azurion 5 M20. Model Numbers: 722228, 722281. 5. Azurion 7 B12. Model Numbers: 722067, 722225. 6. Azurion 7 B20. Model Numbers: 722068, 722226. 7. Azurion 7 M12. Model Numbers: 722078, 722223. 8. Azurion 7 M20. Model Numbers: 722079, 722224, 722282. should stop using it for the purpose described in the recall notice and hold remaining stock pending instructions from PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.. FDA recall records typically direct the recalling firm to notify known accounts directly with a recall letter describing the specific corrective action -- replacement, field correction, refund, or return. Anyone who received the product through a distributor rather than directly from PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. should confirm with their supplier whether their specific lot or unit is on the affected list, since recall notices are lot- or unit-specific and not every unit of a product line is necessarily included. Questions about a specific unit's status should go to PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. directly or to the distributor that supplied it; Argus HQ is a public-record aggregator, not the recalling firm, and cannot confirm individual unit status.

What this classification means

A Class II recall is FDA’s middle classification. FDA assigns Class II when use of, or exposure to, the recalled product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. FDA still requires the recalling firm to notify affected accounts and submit status reports on the correction, though the monitoring intensity is lower than for a Class I recall. FDA's Center for Devices and Radiological Health (for devices) or Center for Drug Evaluation and Research (for drugs) reviews the classification and can require additional corrective action if the initial response is judged insufficient. Because this record is filed as Class II, professionals and consumers handling an affected lot should treat FDA's own classification -- not this page's summary of it -- as the authoritative risk signal. A Class I recall is FDA’s most serious classification. FDA assigns Class I when there is a reasonable probability that use of, or exposure to, the recalled product will cause serious adverse health consequences or death. This classification does not mean harm has already occurred in every case -- it reflects FDA’s assessment of the realistic worst-case risk profile of the defect described in the recall, based on the reason for recall reported by the firm. Class I recalls receive the closest FDA monitoring of the three classes: the recalling firm typically must submit a recall strategy, periodic status reports, and effectiveness checks confirming that the affected lots have actually been removed from distribution or corrected in the field.

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.’s FDA history

Argus HQ has recorded 199 total FDA actions tied to PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: 0 warning letters, 199 recalls, 0 approval records, and 0 Form 483 inspection citations.

Frequently asked questions

Why was Philips Azurion Systems with software versions R2.1.10 and R recalled?

FDA's recall record states the reason as: Six (6) identified software issues which may result in the following: system keeps restarting, AMC triple drive, C-Partition of Suite PC running out of free space, system remains in continuous restart mode after the start-up, misalignment of Market Tool Overlay, and longitudinal positional error.

Who should I contact about this recall?

Contact PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. directly, or the distributor/pharmacy that supplied the product, to confirm whether your specific lot or unit is affected. Argus HQ aggregates the public FDA recall record and is not the recalling firm.

Has PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. had other FDA recalls or enforcement actions?

Yes. Argus HQ has recorded 199 total FDA actions tied to PHILIPS MEDICAL SYSTEMS NEDERLAND B.V., including 199 recalls and 0 warning letters.

What is the FDA recall number for this event?

FDA recall number Z-1091-2026.

Related enforcement actions

• Recall: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: ALLURA Xper FD20 Biplane; System Code: (1) 722008, (2)722013; →
• Recall: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: ALLURA Xper FD20 Biplane OR Table; System Code: (1) 722020, (2)722025; →
• Recall: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Vue Motion V12. Product Number: 1017979. →
• Recall: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Azurion 7 B20; System Code: (1)722068, (2)722226, (3)722236; →
• Recall: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Allura Xper FD10C; System Code: 722001; →
• Recall: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Azurion 5 M20; System Code: (1)722228, (2)722232, (3) 722281 (OUS only); →
• Recall: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Azurion 5 M12; System Code: (1)722227, (2)722231; →
• Recall: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Allura Xper FD20/20 OR Table; System Code: 722039; →