FDA-Device2022-11-16Class II
Sedecal Soltus Battery Mobile X-Ray System REF Soltus 450 Battery Mobile X-Ray System REF Soltus 500
SEDECAL SA
Hazard
Due to un-commanded movement of mobile x-ray unit.
Sold states
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
Affected count
155 systems
Manufactured in
PELAYA, 9 POL., POL. IND. RIO DE JANEIRO, Algete, N/A, Spain
Products
Sedecal Soltus Battery Mobile X-Ray System REF Soltus 450 Battery Mobile X-Ray System REF Soltus 500
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0182-2023Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief