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Allura Xper FD recallZ-0008-2026 · Philips Medical Systems Nederland B.V. · initiated Sep 3, 2025

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Philips Medical Systems Nederland B.V. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Device Design

What the company is doing

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).

Recall details

Recall number
Z-0008-2026
Status
Open, Classified
Initiated by the company
Sep 3, 2025
Posted by the FDA
Oct 1, 2025
Recalling firm
Philips Medical Systems Nederland B.V.
Quantity
298 units (72 US, 226 OUS)
Product code
OWB
FDA submissions
K041949, K130842
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 description

Allura Xper FD20 OR Table; Model Numbers: (1) 722015, (2) 722023, (3) 722035; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

Code information (models, lots, serial numbers)

Show the full code information (2k characters)

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;

Devices named in this recall

2 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other products in the same recall event

The FDA groups related products into one recall event (event 97502).

Sources and updates

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