CLASS II ONGOING Device recall · Reported 8 Oct 2025 · FDA Enforcement Report

Cardio Vascular-Allura Centron recalled by Philips Medical Systems

Philips Medical Systems Nederland B.v is recalling Cardio Vascular-Allura Centron, distributed nationwide in the US. The recall was initiated on 3 Sep 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel 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;

Quantity recalled313 units (OUS only)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0015-2026
FDA event ID: 97502
Recalling firm: Philips Medical Systems Nederland B.v, Best, N/A
Classification: Class II
Status: Ongoing
Recall initiated: 3 Sep 2025
FDA classified: 1 Oct 2025
Reported: 8 Oct 2025
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Heart & Vascular Devices

Timeline

3 Sep 2025	Recall initiated by company
1 Oct 2025	Classified by FDA	+28 days
8 Oct 2025	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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

Where it was distributed

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.

Nationwide Georgia

Questions about this recall

Is Cardio Vascular-Allura Centron recalled?

Yes. Philips Medical Systems Nederland B.v recalled Cardio Vascular-Allura Centron on 3 Sep 2025. The recall is Class II and its status is Ongoing. Recall number Z-0015-2026.

Why was it recalled?

Which lots are affected?

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;

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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