Date Initiated by Firm | December 30, 2019 |
Create Date | March 13, 2020 |
Recall Status1 |
Terminated 3 on November 17, 2022 |
Recall Number | Z-1491-2020 |
Recall Event ID |
84756 |
510(K)Number | K971365 |
Product Classification |
System, x-ray, angiographic - Product Code IZI
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Product | Poly G Integris H5000, System code 72246 |
Code Information |
System equipment number 519212 |
Recalling Firm/ Manufacturer |
Philips North America, LLC 3000 Minuteman Rd Andover MA 01810-1032
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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 | 1 |
Distribution | Nationwide domestic distribution. Foreign distribution worldwide. |
Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = IZI
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