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U.S. Department of Health and Human Services

Class 2 Device Recall Cios Alpha

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  Class 2 Device Recall Cios Alpha see related information
Date Initiated by Firm April 20, 2020
Date Posted May 04, 2020
Recall Status1 Terminated 3 on May 10, 2021
Recall Number Z-1959-2020
Recall Event ID 85553
510(K)Number K181550  
Product Classification Interventional fluoroscopic x-ray system - Product Code OWB
Product Siemens Cios Spin VA30-mobile X-Ray system, Material # 10308194 - Product Usage: The 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 Serial Numbers: 50124 50135 50131 50171 50129 50032 50033 50048 50050 50051 50073 50075 50081 50088 50098 50107 50109 50111 50120 50196 50102 50180 50136 50185 50096 50155 50091 50130 50127 50077 50078 50134 50122 50101 50092 50094 50166 50049 50192 50161 50125 50128 50132 50079 50160 50030 
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		 Main cable can be plugged or unplugged from the X10 connector which is part of the main unit (c-arm) at any time during clinical session. If the system displays the error message Err 16305 / 80, the unplugging of the main cable can cause an unsafe electrical voltage (125 V DC) at the X10 connector and result in an electrical shock if the user or other persons touch the contact pins of the X10 connector. These contact pins are accessible when the main cable is unplugged from the X10 connector
FDA Determined
Cause 2		 Process design
Action Siemens Healthcare issued A Customer Safety Advisory Notice dated 4/20/20 via AX030/20/S. Letter states reason for recall, health risk and action to take: We strongly recommend that you do not disconnect the main unit from the monitor trolley when the system displays the system error message Err 16305 / 80: Confirm this error and repeat your last action until the problem has been corrected by a service engineer. Contact our service organization at 1-800-888-7436. Siemens is currently developing a solution to eliminate the root cause of this problem.
Quantity in Commerce 46 units
Distribution US Nationwide distributions.
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.
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