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Arcoma AB recalls Omnera 400A Digital Radiographic System
Recalled July 13, 2022 · FDA recall Z-1332-2022 · 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). · FDA Class II
Units
47 systems
Sold at
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.
Description
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).
Product
Omnera 400A Digital Radiographic System
Manufacturer(s)
Arcoma AB
Made in
Sweden
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →