Z-1491-2020 Class II Terminated
FDA device recall Z-1491-2020 was initiated by Philips North America, LLC on December 30, 2019 and is designated Class II. 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. The recall status is terminated (terminated November 17, 2022). Affected quantity: 1.
Recall Details
- Product Type
- Devices
- Report Date
- March 25, 2020
- Initiation Date
- December 30, 2019
- Termination Date
- November 17, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1
Product Description
Poly G Integris H5000, System code 72246
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.
Distribution Pattern
Nationwide domestic distribution. Foreign distribution worldwide.
Code Information
System equipment number 519212