Arcoma AB: Medical Device Recall in 2022 - (Recall #: Z-1332-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

Omnera 400A Digital Radiographic System

Product Classification:

Class II

Date Initiated: May 5, 2021

Date Posted: July 13, 2022

Recall Number: Z-1332-2022

Event ID: 90446

Reason for Recall:

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).

Status: Ongoing

Product Quantity: 47 systems

Code Information:

UDI/DI: 07350008750012; 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.

Voluntary or Mandated:

Voluntary: Firm initiated