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U.S. Department of Health and Human Services

Class 2 Device Recall Cios Alpha (VA20)Cios Alpha (VA30)Cios Spin (VA30)

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  Class 2 Device Recall Cios Alpha (VA20)Cios Alpha (VA30)Cios Spin (VA30) see related information
Date Initiated by Firm July 14, 2020
Date Posted August 22, 2020
Recall Status1 Terminated 3 on July 23, 2021
Recall Number Z-2848-2020
Recall Event ID 86116
510(K)Number K181550  K132094  K181560  
Product Classification Interventional fluoroscopic x-ray system - Product Code OWB
Product Cios Alpha (VA20) - Model: 10308191
Cios Alpha (VA30) - Model: 11105200
Cios Spin (VA30) - Model: 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
Code Information S-N Affected systems: 10xxx: 10001; 10003; 10010 10027; 10029 10031; 10033 10040; 10042 10045; 10048 10052; 10054 10110; 10112 10119  11xxx: 11000 11004; 11006 11028; 11030 11101; 11103 11183; 11185 11205; 11207 11372; 11374 11387; 11600 11608  12xxx: 12000 12014; 12016 12024; 12026 12045; 12047 12052; 12054; 12200 12207; 12301 12493; 12495 12505; 12507 12522; 12524 12550; 12552 12571; 12573; 12575 12610; 12612 12746; 12800 12803; 12805 12811; 12813 12889; 12891 12959; 12961 12973; 12975 12999   13xxx: 13000 13085; 13087; 13088; 13092; 13103 13105; 13114; 13121 4xxxx: 416; 40000; 40001; 40003 40021; 40030; 40038; 40070 5xxxx: 50001 50053; 50055; 50075  Expanded Recall: 11143, 12490 
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
40 Liberty Blvd
Malvern PA 19355
For Additional Information Contact SAME
610-219-4834
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 Device Design
Action Siemens Medical Solutions USA, Inc. initiated a Customer Safety Advisory Notice to affected customers via AX013/20/S dated July 14, 2020, The letter states reason for recall, health risk and action to take: We advise urgently to cease the use of the hot plugging feature until the pending hardware update AX014/20/S has been completed. Siemens will correct the hardware error via Update Instruction AX014/20/S in which a Siemens Service Engineer will replace the main control D80. Service organization will contact you shortly to arrange a date to performthis corrective action. Please feel free to contact our service organization for an earlier appointment at 1-800-888-7436. Acknowledge Receipt of this Safety Advisory Notice.
Quantity in Commerce US: 282 units; OUS: 1363
Distribution Nationwide
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = OWB and Original Applicant = Siemens Medical Solutions USA, Inc.
510(K)s with Product Code = OWB and Original Applicant = SIEMENS MEDICAL SOLUTIONS, INC.
510(K)s with Product Code = OWB and Original Applicant = Siemens Medical Systems USA, Inc.
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