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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 February 16, 2016
Create Date March 31, 2016
Recall Status1 Terminated 3 on November 08, 2017
Recall Number Z-1281-2016
Recall Event ID 73546
510(K)Number K132094  
Product Classification Interventional fluoroscopic x-ray system - Product Code OWB
Product CIOS ALPHA (Image-intensified fluoroscope 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.
Code Information Model Number: 10308191
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
40 Liberty Blvd
Malvern PA 19355-1418
For Additional Information Contact Anastasia Sokolova
610-448-4153
Manufacturer Reason
for Recall		 Siemens found a defective part in their production line which could increase risk of an electrical shock for service personnel when working inside the device during system maintenance. The risk of an electrical shock is only present when a service technician ignores several steps listed in the service manual as precautionary actions during device maintenance.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Siemens sent a Customer Safety Advisory Notice dated February 18, 2016 to affected customers. The letter identified the affected product, problem and actions to be taken. The letter informed customers that Siemens is planning to replace the affected parts as a precautionary measure. A Siemens service engineer will contact each customer to schedule implementation of this precautionary measure.
Quantity in Commerce 4 units
Distribution US Nationwide Distributed in the states of AR, CA, NE and UT
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, INC.
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