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U.S. Department of Health and Human Services

Class 2 Device Recall Cios Spin

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  Class 2 Device Recall Cios Spin see related information
Date Initiated by Firm July 30, 2020
Create Date August 26, 2020
Recall Status1 Terminated 3 on May 20, 2021
Recall Number Z-2888-2020
Recall Event ID 86166
510(K)Number K181550  
Product Classification Interventional fluoroscopic x-ray system - Product Code OWB
Product Cios Spin, Image-Intensified Fluoroscopic X-Ray System

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 Cios Spin (VA30)- 10308194
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
40 Liberty Blvd
Malvern PA 19355
For Additional Information Contact Rebecca Tudor
610-219-4834
Manufacturer Reason
for Recall		 Siemens has become aware of a hardware error which affects Cios Spin and Cios Alpha systems after the previous repair of the X-ray Generator with an integrated Energy Storage Unit (ESU).
FDA Determined
Cause 2		 Device Design
Action Siemens sent an "URGENT: MEDICAL DEVICE CORRECTION" letter dated July 27, 2020 to customers. This letter explains the issue that may arise while using the system. The letter instructs users to 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 to avoid potential electrical shock until pending hardware update has been completed. Our service organization will contact you for an appointment to perform the corrective action. Please feel free to contact our service organization at 1-800-888-7436 for an earlier appointment.This letter asks users to acknowledge receipt of the consignee letter by signing and returning the document. If you have any further questions, call 610-219-4834 or rebecca.tudor@siemens-healthineers.com.
Quantity in Commerce 329 units in total
Distribution US Distribution to states of: NC, NE, IL, TX, OH, FL, WI, MN, MD, SC, CA, NY, VA, OK and AZ.
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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