Home / Recalls / PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. / Z-1149-2025

Z-1149-2025 Class I Ongoing

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

FDA device recall Z-1149-2025 was initiated by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. on January 13, 2025 and is designated Class I. Reason for recall: Possibility of the patient falling from the table related to the mattress used on the patient table. The recall status is ongoing. Affected quantity: 302 units (69 US, 233 OUS).

Recall Details

Product Type
Devices
Report Date
February 26, 2025
Initiation Date
January 13, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
302 units (69 US, 233 OUS)

Product Description

Allura Xper FD20/15; Catalog numbers: 722058

Reason for Recall

Possibility of the patient falling from the table related to the mattress used on the patient table.

Distribution Pattern

Worldiwde distribution - US Nationwide and the countries of Afghanistan, Albania, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Brunei Darussalam, Bulgaria, Cambodia, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Ethiopia, Fiji, Finland, France, French Polynesia, Georgia, Germany, Ghana, Gibraltar, Greece, Guadeloupe, Guatemala, Guinea, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, JAMAICA, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of, Kosovo, Kuwait, Kyrgyzstan, Lao People's Democratic Republic, Latvia, Lebanon, Libya, Lithuania, Macao, Macedonia, Malaysia, Maldives, Malta, Martinique, Mauritania, Mauritius, Mexico, Moldova, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Caledonia, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, State of, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Trinidad and Tobago, Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, Viet Nam, Yemen.

Code Information

Catalog number: 722058; UDI-DI: 00884838059115; Serial Numbers: 172, 337, 178, 249, 22, 202, 279, 254, 285, 71, 186, 82, 85, 162, 138, 24, 365, 203, 167, 146, 168, 304, 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, 340, 366, 190, 219, 373, 239, 23, 205, 257, 212, 111, 110, 35, 108, 32, 161, 6, 49, 89, 18, 19, 336, 392, 416, 398, 399, 412, 379, 333, 418, 385, 331, 413, 419, 400, 421, 395, 394, 408, 380, 409, 393, 369, 360, 389, 356, 357, 382, 415, 358, 411, 387, 335, 381, 370, 422, 407, 423, 397, 367, 396, 404, 420, 66, 163, 211, 214, 55, 40, 133, 114, 72, 96, 15, 9, 39, 150, 25, 81, 84, 119, 177, 268, 3, 60, 131, 377, 164, 7, 206, 101, 246, 384, 220, 261, 244, 348, 233, 106, 229, 223, 145, 136, 137, 288, 76, 86, 179, 112, 351, 130, 166, 276, 237, 45, 210, 181, 33, 251, 144, 64, 79, 29, 113, 21, 102, 36, 266, 295, 245, 243, 16, 41, 242, 187, 10, 345, 218, 361, 90, 193, 70, 26, 194, 53, 153, 234, 34, 235, 247, 272, 195, 87, 43, 31, 221, 75, 20, 330, 208, 189, 303, 63, 37, 117, 73, 230, 116, 148, 284, 236, 98, 95, 240, 350, 169, 376, 313, 343, 241, 192, 185, 115, 375, 154, 327, 92, 334, 232, 151, 201, 269, 332, 292, 142, 256, 391, 128, 344, 226, 141, 78, 183, 125, 126, 320, 248, 77, 368, 315, 68, 139, 311, 67, 347, 222, 93, 213, 354, 355, 58, 143, 301, 170, 159, 30, 103, 88, 386, 349, 252, 388, 11, 372, 281, 204, 127, 258, 289, 291, 293, 27, 97, 48, 188, 273,

Other recalls by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

  • Z-2412-2026 Class II — Philips Allura Xper with the following Model Numbers: Model # 722001 for Allura (May 18, 2026)
  • Z-2411-2026 Class II — Philips MultiDiagnost Eleva with the following Model Numbers: Model # 708032 (May 18, 2026)
  • Z-2258-2026 Class II — Azurion system; System Code Description (Model Numbers): Azurion 3 M12 (722063, (April 30, 2026)
  • Z-2259-2026 Class II — Allura system; System Code Description (Model Numbers): Allura Xper FD10 (722003 (April 30, 2026)
  • Z-2227-2026 Class II — Azurion system; System Code Description (Model Numbers): Azurion 3 M12 (722063), (April 28, 2026)
  • Z-2229-2026 Class II — Integris-Allura system; System Code Description (Model Numbers): Integris CV Ces (April 28, 2026)
  • Z-2225-2026 Class II — Philips Azurion systems not configured with an optional auxiliary pan handle. In (April 28, 2026)
  • Z-2228-2026 Class II — Allura system; System Code Description (Model Numbers): Allura Xper FD10C (72200 (April 28, 2026)
  • Z-2170-2026 Class II — Philips Azurion. System Code Description (Model Number): Azurion 3 M12 (722221, (March 31, 2026)
  • Z-1805-2026 Class II — Philips AneurysmFlow. Model Number: 001015. AneurysmFlow is a software medic (March 19, 2026)

FDA data resources