PHILIPS HOME HEALTHCARE SOLUTION Recall 87039
Description: ProxiDiagnost N90 Image-intensified fluoroscopic x-ray system
PHILIPS HOME HEALTHCARE SOLUTION Recall 87039 Information
Status | Ongoing |
Mandated? | FDA Mandated |
Recall Number | Z-0727-2021 |
Event ID | 87039 |
Event Description | ProxiDiagnost N90 Image-intensified fluoroscopic x-ray system |
Product Type | Devices |
Distribution | Nationwide |
Quantity | 91 |
Recall Reason | 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. |
Device Classification | 20210203 |
Device Code Info | Pending |
Center Classification Date | 20201231 |
Recall Initiation Date | 20201208 |
Recalling Firm | PHILIPS HOME HEALTHCARE SOLUTION |
Initial Notification | Letter |
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