Azurion 7 B12 recall

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Catalog numbers: (1) 722067, (2) 722225, (3) 722235 (OUS ONLY); UDI-DI: (1) 00884838085350, (2) 00884838099265, (3) 00884838116788; Serial Numbers: (1) 26, 150, 190, 278, 69, 141, 115, 221, 148, 46, 36, 42, 98, 123, 277, 92, 103, 192, 81, 57, 70, 225, 71, 131, 234, 109, 250, 114, 41, 214, 172, 173, 163, 104, 132, 147, 208, 244, 75, 133, 151, 188, 134, 22, 23, 268, 100, 101, 138, 54, 55, 276, 275, 105, 95, 32, 112, 97, 243, 224, 45, 108, 202, 113, 127, 76, 176, 165, 271, 272, 47, 256, 187, 154, 157, 265, 238, 207, 58, 169, 231, 226, 33, 159, 40, 120, 44, 121, 31, 28, 195, 196, 197, 179, 183, 185, 50, 78, 27, 85, 39, 91, 93, 94, 96, 239, 72, 119, 137, 189, 193, 117, 118, 89, 90, 167, 102, 84, 199, 73, 178, 129, 229, 252, 86, 79, 170, 227, 145, 63, 61, 49, 200, 21, 51, 194, 38, 186, 87, 56, 161, 110, 130, 80, 171, 245, 88, 175, 198, 139, 99, 37, 264, 266, 209, 255, 140, 59, 30, 206, 60, 156, 191, 142, 143, 144, 274, 52, 53, 107, 29, 232, 260, 64, 35, 203, 74, 48, 149, 251, 233, 222, 262, 273, 270, 218, 235, 111, 146, 237, 43, 68, 210, 211, 212, 213, 34, 254, 168; (2) 259, 260, 55, 268, 147, 375, 404, 112, 376, 228, 229, 453, 53, 72, 71, 300, 157, 340, 28, 207, 216, 217, 68, 177, 291, 299, 29, 249, 227, 289, 354, 148, 205, 235, 41, 141, 262, 37, 298, 331, 104, 46, 111, 84, 208, 122, 110, 233, 175, 153, 206, 456, 393, 387, 189, 200, 218, 345, 346, 114, 173, 431, 149, 258, 184, 237, 385, 167, 14, 364, 4, 398, 30, 231, 103, 38, 178, 1, 321, 326, 313, 320, 180, 116, 107, 342, 350, 373, 372, 343, 348, 349, 351, 186, 195, 302, 301, 170, 171, 82, 210, 330, 307, 73, 93, 108, 143, 15, 62, 361, 119, 286, 89, 90, 77, 369, 161, 179, 131, 132, 20, 155, 191, 244, 245, 212, 323, 27, 106, 35, 150, 317, 88, 118, 100, 163, 337, 139, 165, 166, 137, 138, 247, 162, 9, 67, 94, 95, 40, 391, 91, 12, 11, 213, 272, 117, 21, 54, 74, 64, 192, 204, 85, 238, 341, 125, 190, 16, 363, 80, 311, 275, 44, 370, 334, 70, 303, 75, 353, 360, 36, 282, 57, 115, 224, 377, 10, 316, 198, 424, 335, 34, 236, 23, 325, 322, 154, 211, 332, 127, 355, 69, 60, 61, 279, 402, 329, 278, 63, 277, 432, 281, 98, 197, 151, 379, 76, 194, 222, 13, 59, 280, 371, 164, 359, 193, 430, 319, 32, 121, 86, 240, 58, 266, 18, 19, 92, 221, 105, 160, 39, 42, 120, 219, 187, 396, 446, 367, 242, 423, 257, 312, 327, 152, 447, 448, 47, 48, 52, 333, 324, 392, 365, 83, 96, 255, 256, 159, 234, 128, 134, 135, 226, 223, 386, 287, 309, 310, 414, 99, 413, 246, 8, 426, 420, 315, 293, 169, 123, 220, 79, 201, 196, 31, 384, 87, 283, 374, 421, 422, 267, 454, 439, 284, 395, 146, 427, 314, 450, 140, 241, 306, 133, 158, 230, 269, 145, 232, 109, 338, 362, 168, 368, 292, 56, 433, 296, 5, 124, 290, 43, 248, 276, 17, 243, 142, 144, 274, 7, 65, 66, 214 ****Serial Numbers Added 5/2/2025**** 400, 405, 434, 435, 251, 252, 253, 254, 366; (3) OUS ONLY 10, 6, 7, 5, 4, 14 ****Serial Numbers Added 5/2/2025**** 3, 8, 9, 13, 17, 18, 19, 20, 21, 23, 24, 25, 28, 33, 34, 35, 39, 41, 44, 45, 47, 49, 52, 53, 54, 56, 58, 65, 70, 72.

Product

Azurion 7 B12; Catalog numbers: (1) 722067, (2) 722225, (3) 722235 (OUS ONLY).

Recalling firm

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Quantity

602 units (94 US, 508 OUS)

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 date

February 26, 2025

Classification

Class I

Status

Ongoing

Agency

FDA (device)