# FDA recall Z-1331-2022

> **Arcoma AB** · Class II · device recall initiated 2021-05-05.

## Product

Omnera 400T 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).

## 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.

## Key facts

- **Recall number:** Z-1331-2022
- **Recalling firm:** Arcoma AB
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-05-05
- **Report date:** 2022-07-13

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Vaxjo, N/A, Sweden

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1331-2022

## Citation

> AI Analytics. FDA recall Z-1331-2022. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1331-2022. Source: US FDA. Licensed CC0.

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