FDA Device Recall Z-1154-2025

Device

Azurion 3 M15; Catalog numbers: (1) 722064, (2) 722222 (3) 722280(OUS ONLY).

Lot / serial / GTIN: Catalog numbers: (1) 722064, (2) 722222, (3) 722280(OUS ONLY); UDI-DI: (1) 00884838085282, (2) 00884838099210 (3) No UDI; Serial Numbers: (1) 267, 335, 260, 261, 209, 238, 64, 229, 218, 314, 291, 201, 270, 258, 341, 237, 35, 174, 151, 10, 82, 73, 74, 168, 125, 246, 302, 86, 81, 198, 165, 127, 274, 329, 200, 317, 179, 276, 167, 59, 58, 182, 249, 388, 112, 169, 297, 400, 458, 394, 265, 510, 502, 519, 520, 474, 441, 505, 416, 500, 387, 333, 468, 324, 504, 426, 320, 501, 413, 491, 236, 475, 311, 509, 488, 342, 389, 225, 473, 406, 457, 338, 508, 443, 513, 262, 427, 234, 469, 280, 401, 308, 304, 461, 422, 414, 310, 494, 312, 235, 322, 444, 498, 515, 449, 447, 483, 480, 448, 405, 463, 337, 470, 445, 462, 496, 247, 397, 344, 432, 503, 343, 407, 439, 517, 396, 386, 514, 454, 485, 472, 340, 476, 404, 477, 452, 442, 412, 395, 478, 479, 440, 330, 467, 492, 471, 285, 446, 385, 278, 36, 55, 94, 403, 228, 208, 40, 45, 66, 135, 136, 11, 96, 417, 156, 84, 190, 277, 256, 131, 148, 161, 162, 12, 57, 6, 69, 408, 282, 123, 62, 184, 51, 89, 100, 137, 61, 222, 50, 143, 49, 268, 7, 119, 118, 384, 68, 65, 121, 87, 180, 185, 193, 212, 213, 214, 266, 271, 72, 37, 245, 108, 91, 252, 292, 293, 321, 379, 138, 60, 130, 157, 263, 264, 110, 109, 133, 79, 490, 155, 451, 511, 484, 497, 67, 272, 323, 132, 102, 253, 275, 70, 251, 421, 43, 254, 106, 104, 122, 191, 47, 378, 75, 381, 227, 92, 207, 117, 126, 175, 166, 172, 429, 296, 114, 437, 294, 295, 419, 134, 188, 189, 283, 315, 284, 210, 116, 187, 199, 434, 241, 357, 313, 192, 255, 306, 164, 215, 319, 327, 144, 221, 5, 250, 46, 101, 431, 9, 177, 39, 226, 290, 393, 257, 78, 183, 269, 80, 425, 206, 309, 173, 220, 359, 354, 374, 41, 186, 48, 44, 149, 150, 176, 197, 230, 231, 233, 287, 288, 289, 380, 124, 373, 98, 147, 391, 345, 303; (2) 15, 19, 55, 265, 23, 226, 255, 254, 256, 257, 12, 99, 100, 120, 45, 187, 223, 367, 332, 44, 358, 69, 310, 17, 111, 356, 112, 113, 106, 51, 65, 188, 268, 77, 11, 109, 80, 68, 245, 83, 250, 251, 252, 253, 248, 270, 47, 21, 38, 54, 272, 64, 261, 165, 98, 211, 67, 326, 29, 10, 22, 173, 127, 368, 262, 190, 225, 184, 166, 143, 312, 322, 297, 364, 219, 189, 304, 183, 162, 168, 349, 318, 333, 169, 185, 311, 228, 180, 172, 296, 217, 181, 224, 278, 186, 161, 247, 193, 266, 313, 282, 244, 177, 50, 280, 354, 75, 246, 269, 126, 78, 108, 105, 124, 218, 125, 35, 146, 13, 300, 5, 9, 18, 249, 27, 31, 104, 53, 76, 107, 243, 66, 215, 267, 324, 281, 229, 213, 117, 178, 92, 287, 88, 89, 102, 118, 119, 145, 209, 210, 331, 351, 361, 372, 373, 288, 289, 290, 291, 292, 294, 295, 319, 212, 192, 149, 321, 115, 82, 316, 133, 174, 230, 307, 320, 336, 338, 339, 340, 344, 362, 141, 37, 182, 308, 142, 96, 378, 365, 366, 370, 374, 135, 73, 159, 157, 158, 114, 87, 274, 214, 116, 276, 132, 277, 353, 14, 72, 151, 152, 138, 56, 137, 302, 363, 4, 24, 90, 131, 263, 16, 314, 315, 110, 305, 139, 134, 222, 369, 375, 284, 48 ****Serial numbers Added 5/2/2025**** 328, 335,343, 345, 346, 376, 379, 380, 382, 383, 384, 385, 386, 389, 392, 396; (3) (OUS ONLY) 79, 196, 126, 131, 142, 143, 144, 133, 162, 152, 167, 44, 129, 199, 147, 112, 98, 36, 137, 101, 150, 210, 170, 34, 123, 125, 124, 113, 39, 81, 42, 41, 93, 37, 100, 95, 22, 43, 171, 58, 49, 158, 20, 19, 88, 87, 165, 207, 63, 76, 48, 164, 83, 54, 45, 38, 179, 127, 175, 157, 128, 140, 99, 132, 35, 145, 91, 92, 96, 161, 205, 66, 174, 74, 69, 209, 206, 61, 118, 84, 94, 108, 148, 24, 72, 105, 208, 47, 33, 53, 90, 187, 130, 57, 85, 86, 153, 80, 106, 149, 55, 173, 103, 177, 178, 119, 46, 135, 17, 107, 65, 102, 141, 160, 52, 71, 60, 59, 120, 189, 114, 97, 73, 50, 82, 21, 30, 23, 110, 40, 151, 146, 117 ****Serial Numbers Added 5/2/2025**** 68, 138, 194, 197, 198, 204, 211, 212, 215, 216, 218, 220, 226, 231.

Quantity: 735 units (42 US, 693 OUS)

Reason for recall

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

Recall record

Recall number

Z-1154-2025

Classification

Class I

Status

Ongoing

Voluntary or mandated

Voluntary: Firm initiated

Firm notification

Letter

Distribution

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.

Recall initiated

2025-01-13

Classified by FDA Center

2025-02-20

FDA published

2025-02-26

Recalling firm

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Firm location

Best, N/A, Netherlands