PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: Allura Xper FD20 Biplane Product Codes: (1)722013, (2) 722008; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;

Recall number

Z-2627-2025

Recalling firm

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Product

Allura Xper FD20 Biplane Product Codes: (1)722013, (2) 722008; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;

Status

Open, Classified

Initiated

2025-09-03

Posted

2025-09-25

Terminated

not on file

Reason

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

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

268 units (102 US, 166 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.

Lot, serial or model codes

Product Codes: (1)722013, (2) 722008; UDI-DI: (1) 00884838059061, (2) N/A; Serial numbers: (1) 505, 313, 34, 153, 410, 360, 290, 241, 404, 126, 244, 106, 346, 383, 461, 307, 442, 435, 293, 289, 267, 214, 402, 86, 603, 149, 424, 140, 254, 255, 266, 518, 519, 303, 115, 150, 129, 496, 441, 124, 151, 550, 575, 562, 178, 330, 309, 601, 308, 264, 268, 141, 175, 85, 216, 422, 174, 228, 511, 152, 561, 262, 626, 497, 170, 379, 125, 564, 426, 495, 500, 515, 105, 428, 427, 531, 375, 316, 278, 347, 462, 249, 246, 639, 304, 147, 607, 567, 168, 171, 265, 332, 295, 589, 444, 447, 400, 384, 538, 117, 620, 624, 623, 215, 416, 415, 47, 335, 619, 598, 361, 358, 549, 133, 476, 315, 616, 630, 417, 490, 528, 525, 247, 618, 372, 613, 478, 544, 585, 608, 296, 570, 547, 138, 318, 345, 139, 473, 388, 434, 502, 586, 334, 411, 501, 458, 261, 429, 353, 395, 128, 348, 503, 557, 493, 563, 250, 595, 406, 355, 57, 394, 535, 569, 522, 465, 533, 412, 95, 344, 354, 425, 542, 207, 555, 524, 574, 366, 527, 325, 470, 440, 144, 403, 448, 134, 380, 487, 374, 256, 405, 367, 455, 302, 300, 299, 239, 506, 243, 324, 311, 70, 161, 449, 321, 176, 181, 554, 167, 130, 378, 158, 237, 453, 165, 532, 223, 343, 291, 370, 193, 163, 526, 236, 156, 368, 499, 443, 540, 259, (2) 224, 105, 312, 197, 264, 294, 246, 231, 521, 413, 18, 19, 267, 487, 69, 386, 205, 416, 513, 337, 327, 122, 259, 150, 547, 408, 160, 388, 283, 359, 435, 370, 323, 128, 455, 266, 468, 46;

510(k) numbers

["K102005","K130638","K130842","K133292","K141979","K161563"]

PMA numbers

not on file

Product code

OWB

Firm FEI

3002807880

Firm city

Best

Firm state

not on file

Firm country

Netherlands

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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