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FDA (Device enforcement)Recalled 2021-05-05class ii

Arcoma AB: Omnera 400A Digital Radiographic System

Is my product affected?

Omnera 400A Digital Radiographic System

  • UPC 07350008750012

Check against the official notice below — it lists the full affected range.

What happened

The Omnera 400A Digital Radiographic System, manufactured by Arcoma AB, is subject to a recall due to a potential short circuit hazard in the display handles caused by liquid ingress. This short circuit could result in uncontrolled movement of the Overhead Tube Crane (OTC). A total of 47 systems have been distributed nationwide across 23 U.S. states and Canada, with specific lot codes ranging from 2001 to 2236.

The recall notice does not specify a remedy for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

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).

Details from the source

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). Distribution: 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. Quantity: 47 systems Lot/code info: 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.

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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