FDA-Device2015-02-11Class II

MobileDiagnost wDR motorized portable diagnostic X-ray systems.

Sedecal S.A.
Hazard

Reports of unexpected movement.

Sold states
US: Nationwide (AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NM, NY, OH, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI)
Affected count
283 systems
Manufactured in
C/Pelaya, 9-13, Pol. Industrial Rio De Janiero, Algete, N/A, Spain
Products
MobileDiagnost wDR motorized portable diagnostic X-ray systems.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1040-2015

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