—#215823

Product

Cardio Vascular-Allura Centron; Model Numbers: 722400; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

FDA product code: OWB — Interventional Fluoroscopic X-Ray System
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K041949, K130842
Affected lot / code info: Model Numbers: 722400; UDI-DI: N/A; Serial Numbers: 282, 91, 206, 472, 187, 486, 480, 71, 322, 280, 506, 429, 413, 497, 507, 502, 222, 103, 53, 510, 43, 439, 489, 55, 176, 76, 364, 209, 382, 178, 243, 16, 74, 158, 113, 303, 4, 101, 131, 334, 93, 156, 347, 552, 482, 414, 112, 60, 42, 82, 407, 338, 33, 184, 153, 189, 424, 201, 245, 122, 273, 228, 79, 307, 476, 57, 196, 533, 217, 225, 314, 432, 81, 458, 491, 361, 2, 308, 89, 321, 525, 519, 511, 148, 100, 258, 63, 62, 22, 130, 221, 135, 159, 352, 49, 143, 31, 254, 363, 434, 223, 174, 137, 257, 232, 269, 161, 471, 470, 155, 150, 136, 440, 545, 279, 6, 149, 346, 317, 369, 119, 495, 547, 348, 110, 86, 380, 61, 341, 438, 437, 513, 459, 379, 355, 64, 485, 503, 290, 186, 168, 400, 498, 278, 283, 512, 487, 236, 455, 276, 173, 448, 92, 83, 251, 139, 160, 109, 522, 319, 381, 68, 291, 199, 67, 233, 539, 504, 190, 535, 116, 479, 423, 473, 296, 285, 449, 329, 508, 292, 398, 230, 548, 523, 299, 494, 286, 300, 488, 541, 543, 427, 447, 542, 262, 536, 469, 430, 529, 554, 555, 546, 375, 534, 521, 419, 344, 433, 463, 443, 483, 357, 374, 277, 530, 337, 549, 441, 320, 445, 287, 556, 446, 527, 526, 532, 418, 51, 544, 444, 69, 23, 250, 272, 252, 106, 224, 37, 90, 267, 229, 202, 393, 218, 550, 524, 540, 284, 557, 316, 121, 77, 147, 353, 553, 376, 132, 133, 389, 496, 368, 454, 315, 34, 240, 97, 531, 28, 9, 297, 538, 197, 415, 21, 151, 227, 528, 259, 256, 152, 330, 264, 193, 386, 44, 188, 220, 462, 356, 551, 396, 460, 249, 412, 157, 244, 78, 395, 212, 478, 499, 515, 271, 306, 435, 501, 518, 140, 226, 114, 360, 370, 477;

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.

Root cause (FDA determination)

Device Design

Action the firm took

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).

Recalling firm

Firm: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2025-09-03
Posted by FDA: 2025-10-01
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #215823. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.