Z-0727-2021 Class II Terminated
FDA device recall Z-0727-2021 was initiated by PHILIPS HOME HEALTHCARE SOLUTION on December 8, 2020 and is designated Class II. Reason for recall: After the user selects the Lock-in command, the kV and mA values are not locked immediately and can adjust if the collimator shutter position is changed directly after the Lock-in command. The recall status is terminated (terminated June 21, 2024). Affected quantity: 91.
Recall Details
- Product Type
- Devices
- Report Date
- February 3, 2021
- Initiation Date
- December 8, 2020
- Termination Date
- June 21, 2024
- Voluntary/Mandated
- FDA Mandated
- Product Quantity
- 91
Product Description
ProxiDiagnost N90 Image-intensified fluoroscopic x-ray system
Reason for Recall
After the user selects the Lock-in command, the kV and mA values are not locked immediately and can adjust if the collimator shutter position is changed directly after the Lock-in command.
Distribution Pattern
Nationwide
Code Information
Pending