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

Recall Z-2065-2012 — OEC 8800 Flexview, 892.1650 Image-intensified fluoroscopic x-ray system Product Usage: The 8800 Flexview is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical, and interventional procedures. Clinical applications may include cholangiography, urol

U.S. FDA — Device Enforcement · United States · 2006-11-20 · Class I

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2065-2012
Date of alert: 2006-11-20
Country / jurisdiction: United States
Risk level: Class I
Risk type: recall
Brand: GE OEC Medical Systems, Inc
Product category: device
Product type: Devices

Reported risk: Please be aware that this is not a new recall. The firm has taken action; but, due to administrative issues this recall is now being classified by the Agency. The OEC 8800 Flexview was recalled in November 2006 due to several intermittent potential safety issues including navigation tracking inaccuracy, system lok-up, incorrect image display, incorrect dose area calculated air kerma in "film mod

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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