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U.S. Department of Health and Human Services

Class 2 Device Recall Uroskop Omnia

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  Class 2 Device Recall Uroskop Omnia see related information
Date Initiated by Firm September 09, 2020
Create Date January 08, 2021
Recall Status1 Terminated 3 on April 16, 2021
Recall Number Z-0805-2021
Recall Event ID 86985
510(K)Number K101491  
Product Classification System, x-ray, fluoroscopic, image-intensified - Product Code JAA
Product Uroskop Omnia, Model no. 10094910 - Product Usage: a solid state detector fluoroscopic X-ray system, primarily for urological applications (functional x-ray diagnosis, endourology and minimal invasive urology/surgery).
Code Information Serial Nos. 3417 3414 3415 3418 3428 3416 
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
40 Liberty Blvd
Malvern PA 19355
For Additional Information Contact Anastasia Sokolova
610-219-4834
Manufacturer Reason
for Recall		 After the March 2019 corrective action on the monitor support arm, there is a residual risk of the support arm becoming dislodged in cases when the monitor support arm is used intensely over a long period of time.
FDA Determined
Cause 2		 Device Design
Action On September 9, 2020, the firm distributed Urgent Medical Device Correction letters to affected customers. Customers were informed that the firm has released an additional safety measure to avoid the potential issue. A safety gear will be installed into the monitor support arm out of an abundance of caution. The corrective action is available and is being provided to affected users free of charge. The firm will contact customers to arrange a date to perform the corrective action. Please feel free to contact the firm to schedule an earlier appointment at 1-800-888-7436.
Quantity in Commerce 6
Distribution Worldwide distribution.
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 = JAA and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.
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