FDA recall Z-1748-2022

Product

SCENARIA View: Software Version V1.08, V1.09B, V1.09C, V1.09D, V1.0B, V1.0C

Reason for recall

Error 00003050 or 00003052 may occur during scanning, the captured images will not be reconstructed and the Raw Data will not be displayed in the work list.result, may result in the need for additional scanning to capture the images properly for reconstruction, thereby exposing the patient to additional radiation

Distribution

US Nationwide Distribution

Key facts

Status

Ongoing

Initiation date

2022-07-12

Report date

2022-09-21

Voluntary/Mandated

Voluntary: Firm initiated

Location

Lexington, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1748-2022