Recall Record: Class II Recall: Allura system; System Code Description (Model Numbers): Allura… by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Key facts

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 -- Allura system; System Code Description (Model Numbers): Allura Xper FD10 (722003, 722010, 722026), Allura Xper FD10 OR Table (722022, 722033), Allura Xper FD10/10 (722005, 722011, 722027), Allura Xper FD20 (722006, 722012, 722028), Allura Xper FD20 Biplane (722008, 722013) (additional items listed in FDA's full record) -- and the recall number Z-2259-2026. 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.

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: Allura system; System Code Description (Model Numbers): Allura Xper FD10 (722003, 722010, 722026), Allura Xper FD10 OR Table (722022, 722033), Allura Xper FD10/10 (722005, 722011, 722027), Allura Xper FD20 (722006, 722012, 722028), Allura Xper FD20 Biplane (722008, 722013) (additional items listed in FDA's full record). FDA's stated reason for the recall is: It was identified that HDDs used in the PCs of Azurion and Allura systems may show a decrease in performance as they age, particularly beyond six years of service. Issues with an HDD may, depending on the specific system PC in which the affected HDD is installed, result in loss of imaging functionality. Additionally (additional items listed in FDA's full record). The recall is tracked under FDA recall number Z-2259-2026 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.

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

What is the FDA recall number for this event?

FDA recall number Z-2259-2026.

What is the current status of this recall?

Status as recorded by FDA: Ongoing.

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 Allura system; System Code Description (Model Numbers): Allura Xper FD10 (722003, 722010, 722026), Allura Xper FD10 OR Table (722022, 722033), Allura Xper FD10/10 (722005, 722011, 722027), Allura Xper FD20 (722006, 722012, 722028), Allura Xper FD20 Biplane (722008, 722013) (additional items listed in FDA's full record). FDA's record states the reason for recall as: It was identified that HDDs used in the PCs of Azurion and Allura systems may show a decrease in performance as they age, particularly beyond.

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; →