CLASS II ONGOING Device recall · Reported 8 Oct 2025 · FDA Enforcement Report
Allura Xper/10 recalled by Philips Medical Systems
Philips Medical Systems Nederl is recalling Allura Xper/10, 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
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-0003-2026
- FDA event ID
- 97502
- Recalling firm
- Philips Medical Systems Nederl, 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
- Other Medical 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
Allura Xper FD10/10; Model Numbers: (1) 722005, (2) 722011, (3) 722027; 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.
Questions about this recall
Why was it 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.
Which lots are affected?
Model Numbers: (1) 722005, (2) 722011, (3) 722027; UDI-DI: (1) N/A, (2) 00884838059047, (3) 00884838054196; Serial Numbers: (1) 361, 212, 233, 321, 435, 285, 384, 388, 343, 399, 392, 128, 355, 51, 367, 348, 160, 271, 530, 112, 70, 520, 323, 49, 329, 365, 269, 270, 523, 490, 346, 129, 258, 298, 316, 485, 261, 169, 427, 352, 474, 497, 251, 100, 456, 360, 305, 419, 405, 489, 306, 307, 467, 234, 333, 533, 209, 369, 543, 332, 328, 366, 339, 389, 538, 394, 378, 379, 237, 165, 2724, 238, 415, 473, 482, 397, 53, 385, 52, 447, 96, 429, 159, 531, 58, 499, 229, 374, 25, 354, 440, 441, 54, 403, 55, 342, 272, 80, 351, 371, 85, 75, 276, 26, 561, 511, 478, 428, 500, 464, 463, 14, 459, 416, 359, 487, 564, 469, 72, 125, 494, 76, (2) 157, 83, 268, 308, 380, 95, 107, 34, 59, 23, 319, 49, 170, 137, 173, 101, 84, 155, 133, 234, 345, 332, 102, 270, 177, 132, 325, 15, 79, 76, 17, 87, 255, 171, 362, 168, 22, 275, 344, 324, 163, 375, 103, 82, 40, 154, 215, 273, 222, 203, 214, 220, 242, 166, 71, 156, 36, 189, 186, 118, 119, 300, 213, 372, 12, 55, 41, 100, 190, 278, 258, 299, 260, 280, 32, 89, 199, 194, 108, 75, 307, 301, 18, 302, 303, 304, 305, 306, 293, 294, 184, 266, 146, 116, 68, 310, 272, 238, 152, 286, 309, 43, 334, 338, 165, 80, 112, 233, 188, 141, 139, 77, 99, 277, 313, 223, 27, 26, 29, 340, 69, 374, 328, 228, 251, 231, 323, 224, 145, 66, 117, 153, 6, 129, 355, 91, 227, 202, 114, 274, 21, 86, 378, 376, 377, 257, 265, 127, 180, 259, 211, 206, 217, 314, 98, 201, 341, 318, 347, 261, 178, 183, 271, 230, 317, 198, 321, 204, 94, 104, 290, 244, 333, 287, 38, 39, 176, 282, 216, 158, 329, 246, 295, 56, 337, 292, 125, (3) 203, 335, 123, 133, 134, 284, 280, 183, 169, 106, 107, 234, 42, 101, 307, 265, 306, 267, 209, 153, 40, 332, 156, 112, 305, 1, 104, 263, 342, 71, 255, 351, 298, 175, 120, 116, 174, 241, 240, 29, 50, 288, 56, 152, 43, 49, 202, 178, 266, 127, 319, 39, 164, 187, 321, 328, 282, 184, 53, 146, 35, 337, 357, 213, 293, 292, 170, 346, 211, 95, 144, 238, 247, 154, 188, 347, 196, 159, 339, 343, 256, 167, 338, 334, 162, 273, 5, 160, 246, 61, 36, 299, 294, 345, 76, 94, 350, 348, 349, 172, 323, 324, 151, 7, 44, 99, 189, 85, 102, 78, 212, 126, 81, 268, 356, 244, 221, 55, 86, 254, 6, 117, 113, 362, 271, 186, 259, 236, 201, 275, 135, 277, 3, 58, 249, 149, 148, 38, 47, 316, 27, 165, 274, 80, 64, 205, 223, 270, 181, 245, 46, 352, 358, 361, 60, 228, 142, 57, 100, 70, 214, 145, 30, 114, 115, 204, 225, 297, 182, 48, 110, 84, 132, 177, 300, 79, 130, 210, 82, 260, 261, 103, 322, 128, 360, 310, 125, 68, 291, 180, 287, 264, 272, 59, 155, 207, 122, 45, 166, 158, 239, 33, 31, 137, 308, 243, 242, 131, 218, 66, 147, 197, 168, 118, 73, 235, 278, 250, 227, 96, 119, 233, 329, 296, 193, 143, 219, 276, 326, 312, 304, 311, 199, 75, 121, 87, 91, 192, 289, 217, 355, 232, 67, 315, 69, 19, 34, 141, 18, 138, 309, 51, 171, 136, 191, 269, 62, 206, 330, 90, 195, 215, 88, 139, 220, 198, 150, 208, 28, 163, 286, 23, 24, 21, 20, 65;
Where was it sold?
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.
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
14 other products · FDA event 97502This product is part of a recall event; the main page for the event is Allura Xper recalled by Philips Medical Systems.
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