Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

DRX-Compass/DR-FIT X-ray Systems with Firmware version 2.3.2.0/2.3.2.4. For use in Recalled by Carestream Health, Inc. Due to After pressing and releasing the Z-Axis Motorized buttons...

Date: January 30, 2023
Company: Carestream Health, Inc.
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Carestream Health, Inc. directly.

Affected Products

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).

Quantity: 72 units

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Carestream Health, Inc.

Carestream Health, Inc. has 17 total recalls tracked by RecallDetector.

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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report