Z-1992-2021 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- July 14, 2021
- Initiation Date
- March 11, 2021
- Termination Date
- September 18, 2024
- Voluntary/Mandated
- FDA Mandated
- Product Quantity
- 17
Product Description
HydraVision Digital Imaging System Product ID/Reorder Number: 705559 (65KW)
Reason for Recall
Failure to comply with the performance standard for fluoroscopy systems. Per 21 CFR 1020.32(k)(6), the displayed AKR and cumulative air kerma shall not deviate from the actual values by more than ¿ 35 percent. The dosage displayed on the generator console and table display (monitor) is higher than the actual delivered dose.
Distribution Pattern
US Nationwide Distribution and in the country of Canada
Code Information
Product ID/Reorder Number: 705559 (65KW), 705560 (80KW) Model/NDC: HUTSHVDIS