Z-1992-2021 Class II Terminated
FDA device recall Z-1992-2021 was initiated by LIEBEL-FLARSHEIM COMPANY LLC on March 11, 2021 and is designated Class II. 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… The recall status is terminated (terminated September 18, 2024). Affected quantity: 17.
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