Home / Recalls / PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. / Z-0010-2026

Z-0010-2026 Class II Ongoing

Recalled by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Best, N/A

Recall Details

Product Type
Devices
Report Date
October 8, 2025
Initiation Date
September 3, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
300 units (69 US, 231 OUS)

Product Description

Allura Xper FD20/15; Model Numbers: 722058; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

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 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.

Code Information

Model Numbers: 722058; UDI-DI: 00884838059115; Serial Numbers: 337, 178, 249, 22, 202, 279, 254, 285, 71, 186, 82, 85, 162, 138, 24, 365, 203, 167, 146, 168, 304, 172, 200, 123, 129, 149, 259, 4, 197, 134, 38, 290, 171, 56, 264, 238, 199, 61, 156, 99, 65, 59, 109, 100, 305, 319, 215, 278, 124, 196, 405, 325, 265, 378, 277, 274, 94, 182, 366, 340, 190, 219, 373, 239, 23, 205, 257, 212, 111, 110, 399, 72, 332, 92, 142, 67, 106, 335, 360, 415, 11, 114, 151, 93, 232, 395, 292, 380, 183, 349, 261, 15, 375, 161, 78, 368, 9, 372, 288, 252, 320, 213, 293, 389, 169, 97, 336, 25, 143, 133, 192, 49, 412, 201, 89, 66, 163, 170, 77, 273, 35, 222, 229, 248, 334, 384, 40, 268, 240, 258, 289, 269, 226, 244, 48, 141, 391, 241, 164, 381, 281, 154, 246, 127, 315, 256, 233, 348, 204, 396, 7, 185, 95, 131, 377, 60, 68, 206, 101, 150, 333, 84, 398, 313, 3, 39, 344, 376, 382, 370, 387, 419, 394, 407, 413, 392, 411, 358, 409, 385, 416, 367, 379, 331, 418, 356, 421, 369, 420, 397, 357, 408, 393, 388, 108, 211, 126, 125, 301, 12, 30, 355, 354, 159, 139, 128, 81, 58, 96, 343, 177, 115, 19, 18, 311, 220, 386, 291, 327, 214, 145, 223, 137, 136, 119, 103, 404, 27, 32, 350, 400, 422, 423, 347, 73, 43, 55, 194, 189, 237, 230, 221, 247, 116, 242, 29, 37, 276, 345, 166, 179, 53, 87, 303, 90, 112, 245, 148, 41, 234, 208, 117, 193, 76, 236, 266, 130, 235, 251, 86, 31, 195, 144, 330, 63, 295, 70, 187, 79, 10, 33, 75, 361, 153, 284, 102, 21, 64, 45, 36, 181, 351, 272, 210, 243, 20, 98, 34, 16, 218;

Other recalls by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

  • Z-1344-2026 Class II — Azurion 3 M12 System Model Numbers: (1) 722063, (2) 722221, (3) 722229; Softwa (January 26, 2026)
  • Z-1345-2026 Class II — Azurion 3 M15 System Model Numbers: (1) 722064, (2) 722222, (3) 722230, (4)7222 (January 26, 2026)
  • Z-1350-2026 Class II — Azurion 5 M12 System Model Numbers: (1)722227, (2)722231; Software Version Num (January 26, 2026)
  • Z-1351-2026 Class II — Azurion 5 M20 System Model Numbers: (1)722228, (2)722232, (3)722281(OUS only); (January 26, 2026)
  • Z-1349-2026 Class II — Azurion 7 M20 System Model Numbers: (1)722079, (2)722224, (3)722234, (4)722282( (January 26, 2026)
  • Z-1346-2026 Class II — Azurion 7 B12 System Model Numbers:(1) 722067, (2) 722225, (3) 722235; Softwar (January 26, 2026)
  • Z-1348-2026 Class II — Azurion 7 M12 System Model Numbers: (1)722078, (2)722223, (3)722233; Software (January 26, 2026)
  • Z-1347-2026 Class II — Azurion 7 B20 System Model Numbers: (1)722068, (2)722226, (3)722236; Software (January 26, 2026)
  • Z-1068-2026 Class II — Allura Xper FD10; Model Number: 722010; (December 15, 2025)
  • Z-1072-2026 Class II — Allura Xper FD20 OR Table; Model Number: 722023; (December 15, 2025)