FDA recall Z-1992-2021

Product

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

US Nationwide Distribution and in the country of Canada

Key facts

Status

Terminated

Initiation date

2021-03-11

Report date

2021-07-14

Termination date

2024-09-18

Voluntary/Mandated

FDA Mandated

Location

Saint Louis, MO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1992-2021