Z-2633-2025Class II

Allura Xper FD20/15

Name: Z-2633-2025 Allura Xper FD20/15
Creator: Philips Medical Systems Nederland B.v.
Published: 2025-09-03
License: https://open.fda.gov/license/

Philips Medical Systems Nederland B.V. / initiated 2025-09-03 / Open, Classified / root cause: design

FDA source

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. began a recall of Allura Xper FD20/15; Product Code: 722058; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949 on 2025-09-03. FDA classified it as Class II and gives the reason as "Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply unit). If this deterioration occurs, motorized movements of the system...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-2633-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-09-03
Posted: 2025-09-25
Recalling firm: Philips Medical Systems Nederland B.V.
Product: Allura Xper FD20/15; Product Code: 722058; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
Product code: OWB Interventional Fluoroscopic X-Ray System
Reason for recall: Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply unit). If this deterioration occurs, motorized movements of the system will become unavailable. Manual movements of the stand (longitudinal, transversal and rotational for ceiling mounted systems and rotational for floor mounted systems) and table longitudinal movements remain available. Imaging (X-ray) functionality remains available.
Root cause tag: design
FDA root cause: Device Design
Action: On September 3, 2025, URGENT MEDICAL DEVICE CORRECTION letters were sent to customers. Actions to be taken: 1. "Circulate this Urgent Medical Device Correction to all users of the system so that they are aware of the issue and follow the instructions included in the letter. 2. In case the affected system has been transferred to another organization, please send a copy of this Urgent Medical Device Correction to that organization and inform Philips about this transfer through your local Philips representative. 3. Keep this Urgent Medical Device Correction with the documentation of the system until Philips corrects your system. Ensure that the letter is in a place likely to be seen/viewed. 4. Complete and return the response form included in this Urgent Medical Device Correction to Philips promptly and no later than 30 days from receipt. 5. If you experience the issue described in this letter, please report it to your local Philips representative. Actions Planned by Recalling Firm: 1. Philips will be replacing the Geo PC in all affected systems. 2. Philips expects to start replacing the Geo PC units by September 2025. Your local Philips representative will contact you to schedule a visit to confirm if your system has a model Wolfdale (Q35 generation) Geo PC and to plan the replacement of the Geo PC once available. 3. If you need additional information or support concerning these issues, contact your local Philips representative at 1-800-722-9377 (Philips Customer Care Solutions Center).
Quantity in commerce: 98 units (23 US, 75 OUS)
Distribution: Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bangladesh, Belarus, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Cuba, Cyprus, Czech Republic, Denmark, Dominican Rep, Ecuador, Egypt, Estonia, Fiji, Finland, France, FrenchPolynesia, Georgia, Germany, Greece, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kosovo, Lao, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Malta, Martinique, Mauritius, Mexico, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Caledonia, New Zealand, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Fed., Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Taiwan, Tanzania, Thailand, Tunisia, T¿rkiye, Ukraine, United Kingdom, Uruguay, Utd.Arab.Emir., Uzbekistan, Venezuela, Vietnam, Yemen.
Product codes and lots: Product Code: 722058; UDI-DI: 00884838059115; Serial numbers: 249, 22, 71, 85, 138, 24, 167, 168, 129, 149, 259, 134, 38, 56, 61, 99, 59, 109, 100, 124, 94, 23, 111, 110, 108, 32, 161, 89, 18, 19, 409, 66, 55, 40, 72, 15, 9, 25, 81, 119, 60, 164, 7, 101, 106, 145, 136, 137, 76, 112, 130, 45, 144, 64, 79, 29, 21, 16, 10, 90, 70, 153, 34, 43, 31, 75, 20, 63, 117, 73, 116, 148, 95, 68, 139, 67, 93, 354, 58, 115, 154, 92, 142, 256, 128, 141, 78, 183, 125, 126, 143, 170, 30, 11, 127, 27, 97, 48;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2633-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2623-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-10-01	2025-09-25
Z-2624-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-10-01	2025-09-25
Z-2625-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-10-01	2025-09-25
Z-2626-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-10-01	2025-09-25
Z-2627-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-10-01	2025-09-25
Z-2628-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-10-01	2025-09-25
Z-2629-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-10-01	2025-09-25
Z-2630-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-10-01	2025-09-25
Z-2631-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-10-01	2025-09-25
Z-2632-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-10-01	2025-09-25
Z-2633-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-10-01	2025-09-25
Z-2634-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-10-01	2025-09-25
Z-2635-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-10-01	2025-09-25

Product code OWB

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)