FDA recall Z-0867-2022

Product

MODEL: X-RAY R/F SYSTEM FLUOROspeed X1

Reason for recall

It was found that the irradiated x-ray may exceed the xray radiation dose rate specified in CFR 1020.32 in some specific case of fluoroscopic mode due to inadequate adjusting criteria in installation.

Distribution

U.S.: AK, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OR, PA, RI, SC, SD, TN, TX, WA, and WV. O.U.S.: N/A

Key facts

Status

Ongoing

Initiation date

2022-01-10

Report date

2022-04-13

Voluntary/Mandated

FDA Mandated

Location

Torrance, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0867-2022