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

DR 7500 with FF WS These products are permanently installed diagnostic x-ray systems composed of 4 main components: an operator console, over head tube crane, x-ray tube assembly including a collimator and stationary generator. In addition the device can use an x-ray table and /or wallstand/bucky — recall Z-0798-2014

U.S. FDA — Device Enforcement · United States · 2013-11-25 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0798-2014
Date of alert: 2013-11-25
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Carestream Health, Inc.
Product category: device
Product type: Devices

Reported risk: Carestream Health Inc. has issued a recall for the Carestream DRX-Evolution (FF WS and CSJ WS) and the Kodak DirectView DR 7500 System due to the potential for unexpected device movement.

Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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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