FDA recall Z-0654-2022

Product

Digital Angiography System Bransist safire Generator Model D150GC-40

Reason for recall

Due to the inadequate adjusting criteria in installation, the system generator on two Digital Angiography Systems, the irradiated x-ray may exceed the x-ray radiation dose rate in fluoroscopic mode.

Distribution

U.S.: CA, FL, GA, IL, IN, KY, LA, MI, MS, OH, PA, SC, TN, TX and WA O.U.S.: Not provided.

Key facts

Status

Ongoing

Initiation date

2021-12-16

Report date

2022-03-09

Voluntary/Mandated

FDA Mandated

Location

Torrance, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0654-2022