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U.S. Department of Health and Human Services

Class 2 Device Recall Uroskop Omnia Max fluoroscopic Xray system Model 10762473

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  Class 2 Device Recall Uroskop Omnia Max fluoroscopic Xray system Model 10762473 see related information
Date Initiated by Firm February 08, 2019
Create Date March 07, 2019
Recall Status1 Terminated 3 on May 05, 2020
Recall Number Z-0984-2019
Recall Event ID 82211
510(K)Number K101491  
Product Classification System, x-ray, fluoroscopic, image-intensified - Product Code JAA
Product Uroskop Omnia -fluoroscopic X-ray system
Model # 10094910

The Uroskop Omnia is 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 Numbers: 3414 3415 3416 3417 3418 3428  
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
40 Liberty Blvd
Malvern PA 19355-1418
For Additional Information Contact
610-219-4834
Manufacturer Reason
for Recall		 The swivel arm holding the monitors may become dislodged from the carrying arm.
FDA Determined
Cause 2		 Device Design
Action The firm, Siemens, issued an "URGENT: MEDICAL DEVICE CORRECTION "on 2/8/19 to its customers. The letter is identifying the problem, risk, actions to take and corrective action. The customers were instructed to do the following: Immediately examine your inventory and quarantine product subject to recall (if applicable). or To avoid the risk until implementation of the corrective action, it is strongly recommended not to move and position monitors above the system table. As an alternative and if clinically applicable, monitors can also be used when they are left in the parking position. In addition, if you may have further distributed this product, please identify your customers and notify them at once of this product recall. If the device has been sold and is therefore no longer in your possession, please forward this notice to the new owner. The service organization will contact and arrange a date to perform this corrective action with Updated Instruction XP006/19/S. Contact the service organization for an earlier appointment at 1-800-888-7436.
Quantity in Commerce 6
Distribution US Nationwide 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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