FDA-Device2022-07-13Class II
Omnera 400A Digital Radiographic System
Arcoma AB
Hazard
There is the potential for the X-Ray system to short circuit due to an ingress of liquid in the display handles which may result in uncontrolled movement of the Overhead Tube Crane (OTC).
Sold states
US Nationwide distribution in the states of NM, DE, TX, VT, FL, MO, UT, PA, OR, IN, RI, MI, IL, LA, OH, CO, SC, VA, WA, CA, AZ, NV, AR and the country of Canada.
Affected count
47 systems
Manufactured in
Annavagen 1, N/A, Vaxjo, N/A, Sweden
Products
Omnera 400A Digital Radiographic System
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1332-2022Don't want to check this manually?
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