Z-0008-2026Class II

Allura Xper FD20 OR Table; Model Numbers: (1) 722015, (2) 722023, (3) 722035; Associated 510(k)s: K102005...

Name: Z-0008-2026 Allura Xper FD20 OR Table; Model Numbers: (1) 722015, (2) 722023, (3) 722035; Associated 510(k)s: K102005...
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 OR Table; Model Numbers: (1) 722015, (2) 722023, (3) 722035; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563 on 2025-09-03. FDA classified it as Class II and gives the reason as "The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. No user messages...". 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-0008-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-09-03
Posted: 2025-10-01
Recalling firm: Philips Medical Systems Nederland B.V.
Product: Allura Xper FD20 OR Table; Model Numbers: (1) 722015, (2) 722023, (3) 722035; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Product code: OWB Interventional Fluoroscopic X-Ray System
Reason for recall: The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. No user messages are shown before the battery is low on power or depleted.
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 letter to all users of the system so that they are aware of the issue. 2. In case the affected system has been transferred to another organization, please send a copy of this Urgent Medical Device Correction letter to that organization and inform Philips about this transfer through your local Philips representative. 3. Keep this Urgent Medical Device Correction letter 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 to be taken by recalling firm: 1. Philips will replace the BIOS battery in all affected systems. 2. Philips expects to start the implementation of this action in affected devices by November 2025. Your local Philips representative will contact you to schedule a visit to perform this activity in your system once available. 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: 298 units (72 US, 226 OUS)
Distribution: Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cuba, Curacao, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Finland, France, Georgia, Germany, Greece, Guinea, Honduras, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Korea, South, Kosovo, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Malta, Mauritius, Mexico, Mongolia, Morocco, Nepal, Netherlands, New Zealand, Norway, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Trinidad and Tobago, Tunisia, Turkey, T¿rkiye, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Utd.Arab.Emir., Uzbekistan, Venezuela, Vietnam, Yemen.
Product codes and lots: Model Numbers: (1) 722015, (2) 722023, (3) 722035; UDI-DI: (1) N/A, (2) 00884838059085, (3) 00884838054240; Serial Numbers: (1) 12, 2, 16, 8, 23, 3, 13, (2) 27, 116, 12, 175, 98, 35, 72, 142, 179, 46, 64, 110, 124, 66, 117, 109, 42, 138, 83, 82, 127, 75, 118, 41, 146, 33, 165, 121, 3, 169, 101, 103, 129, 10, 105, 90, 107, 100, 47, 159, 137, 119, 164, 70, 95, 177, 2, 158, 86, 34, 132, 9, 108, 31, 112, 173, 114, 170, 172, 4, 14, 85, 13, 88, 25, 67, 94, 87, 57, 125, 73, 106, 16, 96, 58, 99, 38, 141, 32, 84, 68, 134, 79, 52, 56, 69, 37, 21, 53, 123, 157, 102, 126, 145, 144, 15, 135, 152, 149, 60, 150, (3) 243, 123, 38, 85, 101, 117, 212, 21, 172, 183, 252, 236, 88, 57, 143, 125, 145, 161, 244, 119, 100, 165, 47, 126, 127, 52, 247, 131, 124, 89, 169, 46, 245, 246, 242, 74, 30, 192, 60, 59, 196, 216, 187, 121, 34, 222, 72, 111, 128, 227, 174, 144, 28, 84, 130, 263, 132, 25, 98, 134, 35, 226, 190, 3, 6, 1, 249, 109, 251, 232, 207, 158, 160, 237, 163, 79, 248, 253, 94, 80, 250, 154, 69, 97, 148, 170, 195, 26, 122, 96, 107, 142, 58, 166, 235, 230, 265, 83, 53, 32, 164, 56, 40, 11, 10, 62, 221, 257, 255, 229, 256, 254, 261, 260, 238, 113, 258, 241, 188, 259, 267, 167, 204, 43, 33, 37, 104, 233, 114, 108, 153, 70, 65, 191, 77, 110, 225, 75, 76, 193, 185, 186, 129, 103, 71, 92, 151, 201, 208, 149, 205, 19, 50, 51, 61, 211, 99, 12, 15, 198, 82, 105, 136, 194, 23, 200, 116, 48, 13, 106, 95, 206, 168, 203, 146, 81, 156, 45, 173, 49, 64, 171, 184, 102, 17, 215, 29, 231, 16, 202;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0008-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0001-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-08	2025-10-01
Z-0002-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-08	2025-10-01
Z-0003-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-08	2025-10-01
Z-0004-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-08	2025-10-01
Z-0005-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-08	2025-10-01
Z-0006-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-08	2025-10-01
Z-0007-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-08	2025-10-01
Z-0008-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-08	2025-10-01
Z-0009-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-08	2025-10-01
Z-0010-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-08	2025-10-01
Z-0011-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-08	2025-10-01
Z-0012-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-08	2025-10-01
Z-0013-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-08	2025-10-01
Z-0014-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-08	2025-10-01
Z-0015-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-08	2025-10-01

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)