FDA recall Z-0182-2023

Product

Sedecal Soltus Battery Mobile X-Ray System REF Soltus 450 Battery Mobile X-Ray System REF Soltus 500

Reason for recall

Due to un-commanded movement of mobile x-ray unit.

Distribution

U.S.: KY, WI, FL, DE, WV, CA, MO, NY, NC, AL, AR, MS, GA, IL, IA, TN, KS, KY, IN, HI, OH, WY, PA, NV, RI, UT, AZ, OK, MN, ME, MT, WA, VA, SD, MI, LA, and TX O.U.S.: N/A

Key facts

Status

Ongoing

Initiation date

2022-08-12

Report date

2022-11-16

Voluntary/Mandated

Voluntary: Firm initiated

Location

Algete, N/A, Spain

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0182-2023