Azurion 5 M20; Catalog numbers: (1) 722228, (2) 722232 (OUS ONLY), (3) 722281 (OUS ONLY).
Enforcement
- Recall Number
- Z-1156-2025
- Event ID
- 96132
- Classification
- Class I
- Status
- Ongoing
- Product Type
- Devices
- Firm
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- February 26, 2025
- Initiation Date
- January 13, 2025
- Classification Date
- February 20, 2025
- Address
- Veenpluis 4-6, N/A, Best, N/A, N/A, Netherlands
Description
Azurion 5 M20; Catalog numbers: (1) 722228, (2) 722232 (OUS ONLY), (3) 722281 (OUS ONLY).
Possibility of the patient falling from the table related to the mattress used on the patient table.
Catalog numbers: (1) 722228, (2) 722232(OUS ONLY), (3) 722281 (OUS ONLY); UDI-DI: (1) 00884838099234, (2) 00884838116757, (3) no UDI; Serial Numbers: (1) 522, 187, 328, 113, 205, 204, 273, 180, 61, 523, 132, 149, 48, 79, 80, 37, 481, 17, 150, 32, 159, 23, 25, 29, 431, 127, 38, 87, 47, 24, 373, 91, 399, 10, 36, 6, 49, 211, 189, 231, 123, 124, 185, 186, 198, 213, 122, 64, 20, 157, 26, 110, 403, 529, 181, 177, 524, 573, 62, 128, 153, 45, 502, 215, 92, 67, 18, 76, 504, 395, 125, 391, 178, 229, 106, 56, 12, 408, 89, 194, 60, 193, 377, 190, 383, 464, 462, 138, 94, 309, 310, 93, 114, 145, 365, 311, 611, 629, 440, 368, 590, 591, 360, 421, 195, 501, 292, 364, 490, 352, 297, 386, 525, 448, 182, 473, 404, 503, 376, 534, 486, 487, 606, 196, 280, 166, 340, 438, 220, 212, 535, 362, 555, 607, 608, 302, 489, 424, 425, 183, 402, 405, 258, 320, 384, 434, 314, 306, 325, 497, 305, 307, 338, 432, 581, 283, 412, 443, 313, 626, 446, 426, 282, 387, 327, 350, 542, 439, 500, 321, 329, 303, 291, 620, 472, 476, 433, 493, 281, 480, 203, 442, 513, 454, 345, 304, 288, 341, 342, 430, 257, 409, 543, 366, 514, 556, 418, 197, 324, 308, 361, 217, 557, 98, 260, 33, 261, 179, 174, 548, 346, 214, 1, 3, 536, 143, 46, 429, 70, 21, 22, 7, 13, 191, 259, 343, 218, 83, 158, 156, 437, 467, 349, 374, 117, 104, 385, 369, 199, 57, 293, 518, 508, 43, 444, 5, 406, 546, 474, 498, 417, 407, 510, 284, 90, 414, 201, 130, 73, 469, 99, 100, 101, 107, 108, 449, 427, 488, 66, 115, 116, 192, 416, 144, 28, 11, 30, 68, 233, 27, 59, 298, 55, 419, 119, 34, 601, 344, 200, 118, 415, 436, 317, 515, 588, 506, 516, 234, 31, 88, 230, 318, 390, 223, 312, 319, 286, 471, 370, 482, 475, 102, 103, 176, 389, 14, 16, 109, 575, 477, 494, 167, 353, 9, 95, 294, 597, 598, 228, 466, 175, 97, 163, 316, 160, 492, 162, 290, 170, 164, 168, 285, 479, 136, 65, 478, 207, 81, 401, 378, 121, 540, 208, 289, 133, 295, 147, 82, 146, 161, 141, 165, 139, 140, 135, 134, 71, 63, 74, 39, 465, 552, 554, 463, 435, 413, 85, 172, 52, 35, 53, 216, 154, 339, 202, 483, 232, 333, 335, 171, 566, 568, 571, 453, 561, 560, 334, 331, 337, 330, 539, 569, 332, 459, 452, 75, 78, 531, 574, 602, 336, 579, 173, 496, 580, 86, 44, 512, 184, 299, 84, 428, 517 ****Serial Numbers Added 5/2/2025**** 533, 537, 538, 600, 615, 617, 618, 619, 642, 219, 348, 392, 393, 394; (2) OUS ONLY 1 ****Serial Numbers Added 5/2/2025**** 2, 3, 4, 8, 11, 16, 20, 28, 29, 30, 37, 57, 58; (3) OUS ONLY 90, 48, 50, 114, 62, 33, 21, 127, 36, 95, 87, 86, 79, 29, 140, 110, 32, 60, 76, 111, 9, 70, 55, 121, 75, 14, 66, 22, 146, 23, 44, 45, 58, 42, 137, 13, 122, 52, 61, 109, 41, 34, 103, 16, 132, 117, 17, 102, 72, 158, 99, 35, 160, 30, 31, 37, 135, 94, 57, 138, 10, 26, 59, 80, 63, 74, 27, 28, 54, 88, 24, 11, 20, 101, 89, 91, 157, 19, 12, 96, 64, 69 ****Serial Numbers Added 5/2/2025**** 15, 18, 25, 38, 39, 40, 43, 47, 65, 68, 71, 81, 84, 93, 98, 105, 108, 115, 118, 120, 124, 126, 136, 142, 144, 149, 151, 153, 159, 163, 168, 169, 173, 174, 176, 179, 180, 181, 182, 186, 187, 190, 191, 192, 193, 196, 197, 198, 207, 211, 213, 224, 225, 227, 231, 236, 242.
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.
632 units (77 US, 555 OUS)