Reported Sep 2, 2020 · Terminated
Cios Alpha (VA20) - Model: 10308191 Cios Alpha (VA30) - Model: 11105200 Cios Spin (VA30) - Model: 10308194 Cios Alpha…
Siemens Medical Solutions USA, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Siemens Medical Solutions USA, Inc · 40 Liberty Blvd · Malvern, PA · 19355
Is this the product you have?
3 of 3 products
| Model / number | Product as published |
|---|---|
10308191 | Cios Alpha (VA30) |
11105200 | Cios Spin (VA30) |
10308194 | Cios Alpha and Cios Spin are a mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications |
- Lot codes and dates
- S-N Affected systems
10xxx: 100011000310010 1002710029 1003110033 1004010042 1004510048 1005210054 1011010112 10119 11xxx: 11000 1100411006 1102811030 1110111103 1118311185 1120511207 1137211374 1138711600 11608 12xxx: 12000 1201412016 1202412026 1204512047 120521205412200 1220712301 1249312495 1250512507 1252212524 1255012552 125711257312575 1261012612 1274612800 1280312805 1281112813 1288912891 1295912961 1297312975 12999 13xxx: 13000 1308513087130881309213103 131051311413121 4xxxx: 416400004000140003 40021400304003840070 5xxxx: 50001 500535005550075
- Expanded Recall
1114312490
- S-N Affected systems
- Amount recalled
- US: 282 units; OUS: 1363
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was recalled
Hardware error- Hot Plugging feature could cause an electrical malfunction on the main control D80 (below revision 04 installed) of the generator which is part of the main unit (c-arm) and cause permanent loss of imaging functionality.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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