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U.S. Department of Health and Human Services

Class 2 Device Recall OmniDiagnost Eleva Interventional fluoroscopic xray system

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  Class 2 Device Recall OmniDiagnost Eleva Interventional fluoroscopic xray system 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-1490-2020
Recall Event ID 84756
510(K)Number K032046  
Product Classification Interventional fluoroscopic x-ray system - Product Code OWB
Product OmniDiagnost Eleva System codes 708028
708027
Code Information Serial codes 152 49   514 179 611 C@23273 46 560 555 464 14 90 198 15 326 143*003 451 267 FR90-111 417 59 390 164 135 23 143 80 219 24 78 73 15 79 109 624 71 44 576 70 460 62 98 63 620 147 100 68 122 422 12 54 490 97 138 20 130 67 ON100031011SN273 241 435 125 89 47 17 33 134 574  
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 69
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 = OWB and Original Applicant = PHILIPS MEDICAL SYSTEMS, INC.
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