FDAMay 25, 2017device

DRX-Revolution Mobile X-Ray System; MODEL DRXR-1; Catalog # 1019397 (all other countries) and Catalog 1060177 (China only) -- COMMON/USUAL NAME: DRX-Revolution --- The DRX-Revolution is a mobile system used to generate and control X-Rays for diagnostic procedures

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

The hazard

Carestream found a single unit where four screws in the assembly were not applied in the manufacturing process. This could result in separation of the tube and yoke assembly.

What to do

FDA enforcement status: Terminated

Brands named

carestream healthcarestream

Recall history

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

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