MultiDiagnost Eleva with Flat Detector; x-ray system. Product Codes: 708034, 708037, 708038.
Enforcement
- Recall Number
- Z-2305-2016
- Event ID
- 74731
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Philips Electronics North America Corporation
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- August 10, 2016
- Initiation Date
- July 19, 2016
- Classification Date
- August 1, 2016
- Termination Date
- October 8, 2020
- Address
- 3000 Minuteman Rd, Andover, MA, 01810-1032, United States
Description
MultiDiagnost Eleva with Flat Detector; x-ray system. Product Codes: 708034, 708037, 708038.
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
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.
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.
993 total