Medical device recalls Moderate risk

Sedecal S.A. recalls MobileDiagnost wDR motorized portable diagnostic X-ray systems.

Recall date
August 6, 2014
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1040-2015
FDA classification
Class II
Brand / firm
Sedecal S.A.
Sold / distributed
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)

Why it was recalled

Reports of unexpected movement.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

MobileDiagnost wDR motorized portable diagnostic X-ray systems.

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