FDAJanuary 30, 2023device

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 SYST...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Ongoing

Brands named

carestream healthcarestream

UPCs

6088997862161360889978624188

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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