Product Safety Recalls

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Arcoma AB Recall 90446

Description: Omnera 400T Digital Radiographic System

Arcoma AB Recall 90446 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1331-2022
Event ID90446
Event DescriptionOmnera 400T Digital Radiographic System
Product TypeDevices
DistributionUS 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.
Quantity71 systems
Recall ReasonThere 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).
Device Classification20220713
Device Code InfoUDI/DI:07350008750050; 2001-2003, 2006-2044, 2046-2056, 2118-2126, 2128-2131, 2134-2160, 2164-2175, 2177-2195, 2197-2208, 2210-2212, 2214-2224, 2226-2236.
Center Classification Date20220705
Recall Initiation Date20210505
Recalling FirmArcoma AB
Initial Notification Letter
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