# FDA recall Z-1206-2023

> **Carestream Health, Inc.** · Class II · device recall initiated 2023-01-30.

## Product

DRX-Compass/DR-FIT X-ray Systems with Firmware version 2.3.2.0/2.3.2.4.  For use in obtaining diagnostic quality radiographic images to aid the physician with diagnosis.   CATALOG #(s):  8624181 X-RAY SYSTEM CONSOLE PDU 3P 380-480 C/F  8624199 X-RAY SYSTEM CONSOLE PDU 3P 208-240 C/F  8621617 X-RAY SYSTEM CONSOLE PDU 3P 380-480 C/F  8622359 X-RAY SYSTEM CONSOLE PDU 3P 208-240 C/F    Note: PDU is a standalone Power Distribution Unit (PDU), plugged into the hospital outlet, which supplies Alternate Current (AC) to the Overhead Tube Crane (OTC).

## Reason for recall

After pressing and releasing the Z-Axis Motorized buttons on the Tube Head Display, the Overhead Tube Crane (OTC) could potentially continue the movement  unexpectedly to a certain distance which could potentially result in a injury

## Distribution

Worldwide distribution - US Nationwide distribution in the states of California, Idaho, Illinois, Massachusetts, Minnesota, Nevada, North Carolina, Texas Wisconsin and the countries of Argentina, Australia, Brazil, China, Finland, France, INDIA, ITALY, Korea, Malaysia, Poland, Republic of Korea.

## Key facts

- **Recall number:** Z-1206-2023
- **Recalling firm:** Carestream Health, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-01-30
- **Report date:** 2023-03-08

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Rochester, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1206-2023

## Citation

> AI Analytics. FDA recall Z-1206-2023. Retrieved 2026-06-12 from https://api.ai-analytics.org/recall/Z-1206-2023. Source: US FDA. Licensed CC0.

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