Z-3023-2020 Class II Terminated
FDA device recall Z-3023-2020 was initiated by Philips North America, LLC on November 20, 2019 and is designated Class II. Reason for recall: Unexpected increase in peak tube potential (kV) will lead to an increased patient radiation dose. The recall status is terminated (terminated April 4, 2024). Affected quantity: 71.
Recall Details
- Product Type
- Devices
- Report Date
- October 7, 2020
- Initiation Date
- November 20, 2019
- Termination Date
- April 4, 2024
- Voluntary/Mandated
- FDA Mandated
- Product Quantity
- 71
Product Description
ProxiDiagnost N90
Reason for Recall
Unexpected increase in peak tube potential (kV) will lead to an increased patient radiation dose.
Distribution Pattern
United States
Code Information
All ProxiDiagnost N90 systems are affected.