Recall Z-1488-2020
Philips North America, LLC · initiated December 30, 2019
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Integris Allura 9, system codes 722018 722021
Codes / lots: Serial Codes 8 114 64 906187 41 38 119 75 25 87 67 107 32 97
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: Component design/selection
Action taken
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.
Details
- Recall number
- Z-1488-2020
- Initiated
- December 30, 2019
- Terminated
- November 17, 2022
- Product code
- OWB – Interventional Fluoroscopic X-Ray System
- Quantity
- 20
- Distribution
- Nationwide domestic distribution. Foreign distribution worldwide.
- Recalling firm
- Philips North America, LLC, Andover, MA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1486-2020 Class II | Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001…A capacitor inside the converter of the Velara X-ray generator may fail after a large number of surges in a… | 12/30/2019Terminated |
| Z-1487-2020 Class II | Integris Allura 15 & 12, monoplane (system code 722043) and biplane (system code 722044)A capacitor inside the converter of the Velara X-ray generator may fail after a large number of surges in a… | 12/30/2019Terminated |
| Z-1489-2020 Class II | MultiDiagnost Eleva, System codes 722030 722016 722017 708032 708036 708034 708037 708038A capacitor inside the converter of the Velara X-ray generator may fail after a large number of surges in a… | 12/30/2019Terminated |
| Z-1490-2020 Class II | OmniDiagnost Eleva System codes 708028 708027A capacitor inside the converter of the Velara X-ray generator may fail after a large number of surges in a… | 12/30/2019Terminated |
| Z-1491-2020 Class II | Poly G Integris H5000, System code 72246A capacitor inside the converter of the Velara X-ray generator may fail after a large number of surges in a… | 12/30/2019Terminated |
| Z-1492-2020 Class II | UroDiagnost Eleva, system code 708033A capacitor inside the converter of the Velara X-ray generator may fail after a large number of surges in a… | 12/30/2019Terminated |
| Z-1493-2020 Class II | Allura CV20, system code 722031A capacitor inside the converter of the Velara X-ray generator may fail after a large number of surges in a… | 12/30/2019Terminated |
| Z-1494-2020 Class II | Cardio Vascular-Allura Centron, system code 722400A capacitor inside the converter of the Velara X-ray generator may fail after a large number of surges in a… | 12/30/2019Terminated |