Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0800-2015 — DRX-Revolution Mobile X-Ray System, MODEL DRXR-1, Service Code 1243, Catalog Number 1060177 (China) and 1019397 (all other countries) --- Carestream Health, Inc. The DRX-Revolution Mobile X-Ray System is a mobile imaging system that incorporates a self contained x-ray generator, image receptor,

U.S. FDA — Device Enforcement · United States · 2014-11-25 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0800-2015
Date of alert: 2014-11-25
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Carestream Health Inc
Product category: device
Product type: Devices

Reported risk: While servicing a unit at a customer site, a field engineer discovered a broken bolt from the carriage assembly. Carestream has identified an issue related to the DRX-Revolution Mobile X-Ray System in which bolts that secure the x-ray tube assembly/boom to the device mounting block may break. It has been determined that this issue is a result of an improperly assembled part which holds the x-ray

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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