FDA Device recall Z-1097-2013
Iconos R200 C20, Iconos R200 T20, Iconos R100, Iconos MD, Iconos RHD, Luminos RF Classic, Luminos Fusion or Luminos Select
- FDA Device
- Class II
- terminated
- Published 2013-04-17
On 2013-04-17 the FDA classified a Class II recall of Iconos R200 C20, Iconos R200 T20, Iconos R100, Iconos MD, Iconos RHD, Luminos RF Classic, Luminos Fusion or Luminos Select by Siemens Medical Solutions Usa, citing siemens has become aware of a potential malfunction and possible hazard to patients and staff when using the Iconos R200 C20, Iconos R200 T20, Iconos R100, Iconos MD, Iconos RHD,….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1097-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-01-15 |
| Published | 2013-04-17 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | US |
Product
Iconos R200 C20, Iconos R200 T20, Iconos R100, Iconos MD, Iconos RHD, Luminos RF Classic, Luminos Fusion or Luminos Select. Angiographic x-ray system.
Reason
Siemens has become aware of a potential malfunction and possible hazard to patients and staff when using the Iconos R200 C20, Iconos R200 T20, Iconos R100, Iconos MD, Iconos RHD, Luminos RF Classic, Luminos Fusion or Luminos Select. This malfunction is possible in cases where the table vertical lift movement is obstructed by a solid object which could potentially result in collision. This can re
Identifiers
| code_info | Model Number 5902767 with serial numbers 2217, 2038, 1228, 1007, 1219, 2156, 2264, 2190, 2132, 2213, 1484, 2166, 2259,…Model Number 5902767 with serial numbers 2217, 2038, 1228, 1007, 1219, 2156, 2264, 2190, 2132, 2213, 1484, 2166, 2259, 2068, 1610, 1601, 1413, 2236, 2153, 1444, 1477, 1632, 2037, 2180, 1663, and 1612; Model Number 5902783 with serial numbers 1003, 1401, 1402, and 1405; Model Number 7152478 with serial numbers 2580, 2524, 2590, 2536, 2563, and 2534; Model Number 10093962 with serial numbers 5837, 5120, 5523, 5910, 5507, 6141, 4112, 6274, 4506, 5900, 4121, 6245, 6242, 4509, and 6113. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1097-2013%22
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