FDA Device recall Z-1298-2019
Cios Alpha, Model Number 10308191 Mobile X-ray system - Product Usage: The Cios Alpha is a mobile X-Ray system designed to provide X-ray im…
- FDA Device
- Class II
- terminated
- Published 2019-05-15
On 2019-05-15 the FDA classified a Class II recall of Cios Alpha, Model Number 10308191 Mobile X-ray system - Product Usage: The Cios Alpha is a mobile X-Ray system designed to provide X-ray im… by Siemens Medical Solutions Usa, citing continuous operation at very high tube output may result in increased wear of the radiation emitting components. This may occur when tube voltages of 125 kV are used for a long pe….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1298-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-03-18 |
| Published | 2019-05-15 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | US |
Product
Cios Alpha, Model Number 10308191 Mobile X-ray system - Product Usage: The Cios Alpha is a mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications. Clinical applications may include but are not limited to interventional fluoroscopic, gastro-intestinal, endoscopic, urologic, pain management, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures. The patient population may include pediatric patients.
Reason
Continuous operation at very high tube output may result in increased wear of the radiation emitting components. This may occur when tube voltages of 125 kV are used for a long period, e.g. 30 minutes or more of continuous use. As a result, risk of premature failure of the Monoblock and loss of imaging X-rays.
Identifiers
| code_info | Serial Numbers: 11294 11202 12006 12009 13098 13016 12823 13011 11163 13009 13059 12662 11032 11311 1300…Serial Numbers: 11294 11202 12006 12009 13098 13016 12823 13011 11163 13009 13059 12662 11032 11311 13007 11258 11379 11380 12530 12334 11376 12426 11336 11132 11295 13004 13121 11044 12859 11005 11333 11386 10076 12677 10115 11291 11056 11287 12319 12529 12617 12623 12657 12876 12886 13048 13050 13105 13109 13110 12848 12574 12597 12647 13002 12875 12810 10078 12306 12317 12874 11119 12576 12678 12513 12592 12490 12885 11200 11281 11283 12425 12023 13070 12396 12920 11285 11103 11105 11257 11074 12379 11013 10021 11330 11066 13012 10057 11143 11077 11319 11240 11349 13082 11098 12815 12339 11153 11372 10037 11328 13008 12308 10063 11106 12373 12584 11067 10082 12026 12027 11168 12492 10019 11317 10035 11198 12040 12307 12440 11165 12611 11094 11226 11370 12970 12377 12861 10089 11082 11080 11009 11018 10058 12321 12718 12004 12999 11378 11167 112 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1298-2019%22
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