Omnera 400A Digital Radiographic System — Class II medical device recall Z-1332-2022
Ongoing recall by Arcoma AB, reported 2022-07-13, distributed nationwide. There is the potential for the X-Ray system to short circuit due to an ingress of liquid in the display handle
| Recall number | Z-1332-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Arcoma AB, Vaxjo, N/A, Sweden |
| Recall initiated | 2021-05-05 |
| Classified | 2022-07-05 |
| Reported by FDA | 2022-07-13 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 47 systems |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 07350008750012 |
Product
Omnera 400A Digital Radiographic System
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).
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1332-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.