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FDA (Device enforcement)Recalled 2025-09-03class ii

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: Cardio Vascular-Allura Centron; Model Numbers: 722400; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

Hazard

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.

Details from the source

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. 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, H Quantity: 313 units (OUS only) 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, 47

Source

Official record: FDA (Device enforcement)

Republished from the official source above; details can change — the source record controls.

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