Azurion 5 M12; Catalog numbers: (1) 722227, (2) 722231 (OUS ONLY).

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

Code information: Catalog numbers: (1) 722227, (2) 722231(OUS ONLY); UDI-DI: (1) 00884838099227, (2) 00884838116740; Serial Numbers: (1) 276, 238, 264, 63, 88, 135, 261, 19, 62, 83, 171, 191, 240, 133, 100, 93, 202, 115, 46, 134, 56, 53, 151, 99, 55, 54, 157, 158, 28, 241, 234, 164, 82, 299, 32, 12, 16, 272, 72, 64, 242, 176, 95, 2, 286, 75, 145, 71, 262, 143, 36, 120, 112, 5, 6, 7, 74, 188, 253, 280, 40, 87, 102, 146, 147, 77, 122, 141, 14, 15, 4, 163, 47, 48, 3, 1, 13, 123, 86, 269, 92, 173, 174, 121, 204, 258, 126, 245, 231, 81, 199, 166, 308, 105, 124, 49, 31, 26, 108, 247, 287, 170, 61, 292, 183, 168, 197, 195, 194, 149, 138, 140, 43, 273, 21, 17, 210, 22, 37, 221, 218, 219, 114, 101, 217, 220, 111, 294, 59, 85, 160, 67, 148, 96, 30, 20, 29, 263, 196, 137, 84, 236, 198, 118, 304, 23, 172, 230, 38, 159, 187, 125, 73, 60, 203, 211, 91, 52, 226, 216, 161, 128, 44, 206, 233, 103, 243, 260, 80, 281, 154, 252, 127, 205, 180, 106, 79, 98, 104, 293, 110, 113, 109, 177, 248, 227, 94, 259, 229, 301, 222, 162, 153, 300, 107, 167, 200, 142, 90, 69, 251, 268, 290, 309, 310, 316, 256, 228, 57, 184, 116, 165, 282, 178, 11, 35, 209, 132, 131, 58, 130, 18, 8, 9, 215, 249, 41, 270, 179, 24, 285, 305, 250, 25, 298, 156, 76, 155, 65, 213, 192, 239, 315, 89, 175, 257, 246, 136, 307, 181 ****Serial Numbers Added 5/2/2025**** 265, 271, 360, 311, 313, 318, 319, 320, 321, 323, 324, 329, 330, 331, 332, 333, 334, 335, 337, 339, 346, 350, 352, 355. (2) OUS ONLY 2, 3. ****Serial Numbers Added 5/2/2025**** 1, 4, 5, 11, 20.

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.