FDA Class II Recall: Azurion system; System Code Description (Model Numbers): Azurion… by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Recall Details

Key facts

What this classification means

FDA classifies a recall as Class II when using the recalled product, or being exposed to it, may cause temporary or medically reversible adverse health consequences, or when the probability of serious adverse health consequences is remote. In this case, the recalling firm is PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. and the affected product is described in FDA's record as: Azurion system; System Code Description (Model Numbers): Azurion 3 M12 (722063), Azurion 3 M15 (722064), Azurion 7 B12 (722067), Azurion 7 B20 (722068), Azurion 7 M12 (722078), Azurion 7 M20 (722079, 722224).. FDA's stated reason for the recall is: The deaeration hose in X-ray tube cooling units type CU3101, manufactured between February 2016 and May 2020, may degrade over time, potentially resulting in oil leakage. Oil leakage may affect the cooling performance of the X-ray tube. When the oil flow drops below a certain threshold, the system automatically (additional items listed in FDA's full record). The recall is tracked under FDA recall number Z-2227-2026 and carries a status of Ongoing as of the most recent FDA enforcement report. This classification reflects FDA's assessment of the product defect described above, not a prediction about any specific patient outcome. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do.

What consumers should do

Because this recall carries FDA's middle severity classification, anyone who has this product should stop using it and follow the recalling firm's instructions, even though serious harm is considered unlikely for this classification. Specifically, check whether the product in your possession matches the description on file with FDA -- Azurion system; System Code Description (Model Numbers): Azurion 3 M12 (722063), Azurion 3 M15 (722064), Azurion 7 B12 (722067), Azurion 7 B20 (722068), Azurion 7 M12 (722078), Azurion 7 M20 (722079, 722224). -- and the recall number Z-2227-2026. If it matches, stop using or distributing it and contact PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. or the point of purchase for return or replacement instructions. Retailers and distributors holding affected inventory should quarantine it and follow the firm's written recall notice.

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

Where can I verify this recall directly with FDA?

The verbatim FDA record is the source of truth for every recall Argus HQ tracks — always confirm against fda.gov before acting.

What was recalled and why?

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalled Azurion system; System Code Description (Model Numbers): Azurion 3 M12 (722063), Azurion 3 M15 (722064), Azurion 7 B12 (722067), Azurion 7 B20 (722068), Azurion 7 M12 (722078), Azurion 7 M20 (722079, 722224).. FDA's record states the reason for recall as: The deaeration hose in X-ray tube cooling units type CU3101, manufactured between February 2016 and May 2020, may degrade over time, potentially resulting in oil leakage. Oil leakage may affect the cooling performance of the X-ray tube. When.

How serious is this recall?

FDA classifies a recall as Class II when using the recalled product, or being exposed to it, may cause temporary or medically reversible adverse health consequences, or when the probability of serious adverse health consequences is remote.

What should someone who has this product do?

Because this recall carries FDA's middle severity classification, anyone who has this product should stop using it and follow the recalling firm's instructions, even though serious harm is considered unlikely for this classification. Check the product against FDA's description (Azurion system; System Code Description (Model Numbers): Azurion 3 M12 (722063), Azurion 3 M15 (722064), Azurion 7 B12 (722067), Azurion 7 B20 (722068), Azurion 7 M12 (722078), Azurion 7 M20 (722079, 722224).) and recall number Z-2227-2026, then follow PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.'s recall instructions.

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; →