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U.S. Department of Health and Human Services

Class 2 Device Recall UroDiagnost Eleva System, xray, angiographic

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  Class 2 Device Recall UroDiagnost Eleva System, xray, angiographic see related information
Date Initiated by Firm December 30, 2019
Create Date March 13, 2020
Recall Status1 Terminated 3 on November 17, 2022
Recall Number Z-1492-2020
Recall Event ID 84756
510(K)Number K911098  
Product Classification Table, radiographic, tilting - Product Code IXR
Product UroDiagnost Eleva, system code 708033
Code Information Serial numbers 64 48 2 60 
Recalling Firm/
Manufacturer		 Philips North America, LLC
3000 Minuteman Rd
Andover MA 01810-1032
For Additional Information Contact Technical Support Line
800-722-9377
Manufacturer Reason
for Recall		 A capacitor inside the converter of the Velara X-ray generator may fail after a large number of surges in a short period of time. When this occurs, no image acquisition is possible.
FDA Determined
Cause 2		 Component design/selection
Action On December 30, 2019, the firm notified customers via Medical Device Correction letter. Customers were informed of the product issue and advised to do the following: If the capacitor of the Velara X-Ray fails as described (capacitor failure after large number of surges in a short period of time), please switch off the system, take it out of service immediately, and contact your local Philips representative. The firm will be resolving the issue by replacing a Printed Circuit Board (PCB) in the convertor, which prevents the capacitor from failing. PCB replacements started in January 2020. Customers will be contacted by their local Philips representatives to schedule a date for the PCB replacement. Customers with further questions should contact the Technical Support Line: 1-800-722-9377.
Quantity in Commerce 4
Distribution Nationwide domestic distribution. Foreign distribution worldwide.
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 = IXR and Original Applicant = PHILIPS MEDICAL SYSTEMS, INC.
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