Device product
Allura Xper FD20/15; Catalog numbers: 722058
Z-1149-2025
Product summary
- Event
- Event 96132
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 302 units (69 US, 233 OUS)
- Official record key
device-enforcement:Z-1149-2025
Official wording
Reason: Possibility of the patient falling from the table related to the mattress used on the patient table.
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,
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.
Derived failure modes
-
Unknown
Possibility of the patient falling from the table related to the mattress used on the patient table.