Arcoma AB Recall 90446
Description: Omnera 400A Digital Radiographic System
Arcoma AB Recall 90446 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1332-2022 |
| Event ID | 90446 |
| Event Description | Omnera 400A Digital Radiographic System |
| Product Type | Devices |
| 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 |
| Recall 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). |
| Device Classification | 20220713 |
| Device 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. |
| Center Classification Date | 20220705 |
| Recall Initiation Date | 20210505 |
| Recalling Firm | Arcoma AB |
| Initial Notification | Letter |
| Similar To |