FDA recall Z-1396-2018

Product

Brilliance 64 with 4.1.7 XX026 software version model number 728231 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient and equipment supports, components, and accessories

Reason for recall

Surview scan with tube current lower than 30 mA is unable to be initialized.

Distribution

Worldwide Distribution - US Nationwide in the states of GA, VA, MI, AZ, and the countries of Canada, Switzerland

Key facts

Status

Terminated

Initiation date

2018-02-21

Report date

2018-04-25

Termination date

2020-04-10

Voluntary/Mandated

Voluntary: Firm initiated

Location

Cleveland, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1396-2018