FDA Device recall Z-2305-2016
MultiDiagnost Eleva with Flat Detector
- FDA Device
- Class II
- terminated
- Published 2016-08-10
On 2016-08-10 the FDA classified a Class II recall of MultiDiagnost Eleva with Flat Detector by Philips Electronics North America, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2305-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-07-19 |
| Published | 2016-08-10 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Philips Electronics North America |
| Distribution | US |
Product
MultiDiagnost Eleva with Flat Detector; x-ray system. Product Codes: 708034, 708037, 708038.
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
Identifiers
| code_info | All serial numbers. 708034 System serial numbers 6, 264, 112, 106, 233, 136, 31, 83, 224, 144, 71, 123, 5, 249, 134,…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, 12 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2305-2016%22
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