MultiDiagnost Eleva with Flat Detector recall
MultiDiagnost Eleva with Flat Detector; x-ray system. Product Codes: 708034, 708037, 708038.
Why was MultiDiagnost Eleva with Flat Detector recalled?
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
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
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?
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.
- Product
- MultiDiagnost Eleva with Flat Detector; x-ray system. Product Codes: 708034, 708037, 708038.
- Recalling firm
- Philips Electronics North America Corporation
- Quantity
- 993 total
- Distribution
- 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.
- Recall date
- August 10, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)