FDA Device recall Z-1331-2022
Omnera 400T Digital Radiographic System
- FDA Device
- Class II
- ongoing
- Published 2022-07-13
On 2022-07-13 the FDA classified a Class II recall of Omnera 400T Digital Radiographic System by Arcoma Ab, citing 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 Cran….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1331-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-05-05 |
| Published | 2022-07-13 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Arcoma Ab |
| Distribution | US |
Product
Omnera 400T Digital Radiographic System
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).
Identifiers
| 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. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1331-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.