FDA Device recall Z-0015-2026

Cardio Vascular-Allura Centron

FDA Device
Class II
ongoing
Published 2025-10-08

On 2025-10-08 the FDA classified a Class II recall of Cardio Vascular-Allura Centron by Philips Medical Systems Nederland B V, citing 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 sy….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-0015-2026
Classification	Class II
Status	ongoing
Initiated	2025-09-03
Published	2025-10-08
Last updated	2026-09-13 11:57 UTC
Company	Philips Medical Systems Nederland B V
Distribution	US

Product

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

Reason

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.

Identifiers

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,… 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

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,…

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

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0015-2026%22

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