Omnera 400T Digital Radiographic System
Check against the official notice below — it lists the full affected range.
Arcoma AB is recalling 71 Omnera 400T Digital Radiographic Systems distributed nationwide across 23 U.S. states and Canada. The systems are potentially hazardous because liquid can enter the display handles and cause the X-Ray system to short circuit, which may result in uncontrolled movement of the Overhead Tube Crane (OTC). The affected systems were manufactured between 2001-2003 and 2006-2212, identified by UDI/DI 07350008750050 and specific lot codes.
The source document does not specify a remedy or corrective action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
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).
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: 71 systems Lot/code info: 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.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.