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Recall Observatory FDA recall evidence

Device product

MultiDiagnost Eleva with Flat Detector; x-ray system. Product Codes: 708034, 708037, 708038.

Z-2305-2016

July 19, 2016

Class II

Product summary

Firm
Philips Electronics North America Corporation
Event
Event 74731
Status
Terminated
Classification
Class II
Quantity
993 total
Official record key
device-enforcement:Z-2305-2016

Official wording

Reason: The two bolts that attach the clamping plate to the lateral shaft may break, which could cause the c-arm to move laterally forward, slide out of its bearings, and sag

Code information: All serial numbers. 708034 System serial numbers 6, 264, 112, 106, 233, 136, 31, 83, 224, 144, 71, 123, 5, 249, 134, 103, 266, 97, 132, 61, 19, 82, 196, 3, 12, 39, 244, 197, 119, 204, 75, 151, 69, 70, 37, 115, 55, 200, 180, 175, 78, 93, 234, 130, 142, 53, 113, 65, 27, 242, 202, 14, 208, 247, 261, 225, 28, 11, 110, 25, 128, 171, 81, 237, 211, 54, 76, 163, 207, 216, 122, 135, 205, 63, 238, 254, 262, 72, 1, 206, 187, 52, 143, 154, 155, 156, 73, 150, 98, 248, 80, 22, 133, 209, 167, 265, 105, 217, 79, NTS0427, 129, 13, 15, 16, 17, 18, 24, 84, 146, 41, 190, 10, 194, 125, 268, 177, 109, 42, 43, 44, 172, 213, 181, 212, 189, 26, 95, 9, 4, 117, 251, 2, 48, 183, 157, 245, 116, 62, 56, 160, 152, 127, 94, 174, 176, 259, 50, 58, 51, 277, 68, 159, 77, 40, 199, 253, 114 257, 246, 23, 147, 162, 29, 66, 47, 179, 221, 126, 195, 220, 161, 46, 182, 278, 138, 222, 269, 36, 96, 201, 137, 223, 228, 219, 60, 272, 111, 35, 85, 186, 38, 120, 170, 185, 32, 64, 30, 100, 101, 104, 235, 34, 148, 149, 67, 118, 121, 241, 210, 191, 255, 168, 273, 33, 240, 131, 88, 8, 193. 708037 System Serial numbers 48, 85, 17, 53, 2, 125, 170, 180, 157, 33, 49, 200, 18, 84, 216, 36, 116, 234, 201, 135, 236, 39, 96, 34, 19, 54, 132, 5, 154, 83, 151, 29, 21, 110, 175, 228, 183, 20, 4, 91, 69, 44, 205, 89, 164, 240, 165, 13, 51, 121, 174, 120, 43, 160, 185, 171, 23, 209, 95, 144, 50, 141, 156, 80, 94, 150, 190, 41, 10, 113, 93, 98, 196, 38, 64, 86, 72, 73, 230, 56, 22, 140, 181, 192, 37, 12, 191, 195, 155, 221, 182, 133, 246, 149, 169, 61, 62, 100, 101, 102, 103, 219, 226, 227, 46, 97, 99, 55, 3, 7, 8, 63, 233, 106, 114, 206, 207, 108, 213, 32, 163, 24, 92, 176, 212, 179, 14, 193, 214, 6, 30, 173, 222, 146, 115, 90, 177, 59, 25, 189, 118, 218, 153, 107, 161, 31, 27, 112, 42, 104 76, 26, 217, 35, 124, 139, 15, 66, 241, 245, 40, 239, 123, 58, 88, 172, 129, 81, 136, 159, 244, 238, 82, 65, 249, 70, 142, 188, 178, 158, 128, 117, 148, 45, 203, 79, 229, 199, 119, 126, 152, 71, 52, 60, 197, 198, 87, 105. 708038 System serial numbers 158, 146, 196, 164, 37, 63, 213, 209, 218, 252, 255, 256, 7, 96, 170, 45, 173, 100, 51, 155, 83, 210, 90, 212, 159, 217, 226, 1, 53, 181, 163, 140, 47, 95, 148, 39, 26, 10, 114, 108, 71, 141, 115, 61, 16, 42, 33, 14, 36, 106, 112, 35, 137, 48, 60, 157, 25, 50, 54, 156, 116, 12, 68, 105, 3, 11, 161, 204, 205, 15, 232, 9, 220, 109, 227, 224, 201, 250, 251, 91, 92, 93, 207, 72, 228, 171, 118, 57, 189, 132, 129, 216, 138, 29, 24, 31, 2, 119, 139, 5, 28, 49, 22, 23, 208, 80, 98, 30, 125, 193, 167, 168, 169, 75, 81, 131, 221, 211, 41, 160, 192, 43, 44, 154, 97, 6, 219, 8, 79, 135, 88 107, 65, 194, 126, 69, 247, 248, 249, 13, 215, 78, 243, 245, 246, 175, 38, 177, 253, 191, 32, 259, 235, 264, 258, 52, 67, 111, 257, 94, 142, 143, 260, 121, 236, 268, 265, 74, 101, 182, 174, 124, 239, 4, 172, 263, 254, 149, 151, 64, 183, 184, 76, 152, 188, 261, 242, 244, 34, 162, 147, 241, 134, 178, 237, 176.

Distribution pattern: Worldwide distribution. US nationwide, Canada, Algeria, ARGENTINA, Australia, Austria, Belgium, China, Colombia, Czech Republic, Denmark, Egypt, Estonia, Faroe Islands, Finland, France, French Guiana, Germany, Greece, Hong Kong, Indonesia, Ireland, Israel, Italy, Jersey, Jordan, Republic of Korea, Latvia, Lebanon, Luxembourg, Malaysia, Mexico, Netherlands, New Zealand, Norway, Oman, Philippines, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Thailand, TURKEY, Ukraine, United Arab Emirates, and United Kingdom.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The two bolts that attach the clamping plate to the lateral shaft may break, which could cause the c-arm to move laterally forward, slide out of its bearings, and sag