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Recall Observatory FDA recall evidence

Device product

Omnera 400T Digital Radiographic System

Z-1331-2022

May 05, 2021

Class II

Product summary

Firm
Arcoma AB
Event
Event 90446
Status
Ongoing
Classification
Class II
Quantity
71 systems
Official record key
device-enforcement:Z-1331-2022

Official wording

Reason: 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).

Code information: UDI/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.

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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).