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

Recall Z-0090-2014 — DRX Revolution Mobile X-Ray System, Model DRXR-1, Verona Street Rochester, NY 14608 Catalog Numbers 1019397, 1023415, 1023423 --- Made in USA by Carestream Health, Inc. 150 The device is designed to perform radiographic x-ray examinations on all pediatric and adult patients, in all patient tr

U.S. FDA — Device Enforcement · United States · 2013-07-26 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0090-2014
Date of alert: 2013-07-26
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Carestream Health, Inc.
Product category: device
Product type: Devices

Reported risk: During an audit, Carestream discovered a DRX-1 System that captured an image which displayed an artifact. This issue was discovered in manufacturing. It occurs when the DRX product console software is updated to v5.6b software and the detector is not calibrated before use.

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

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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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