Class II — Arcoma AB
| Recalling firm | ARCOMA AB |
|---|---|
| Registered facility | ARCOMA AB (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| 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). |
| Product | Omnera 400T Digital Radiographic System |
| Quantity | 71 systems |
| 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. |
| Initiated | 2021-05-05 |
| Classified | 2022-07-05 |
| Recall number | Z-1331-2022 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Arcoma AB (Z-1331-2022).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/90446/
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