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

Recall Z-2026-2012 — OEC 9800, OEC FluoroTrak 9800 Plus, OEC 9800 Plus, OEC 9800 MD Motorized C-arm System designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. The OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the pati

U.S. FDA — Device Enforcement · United States · 2007-11-19 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2026-2012
Date of alert: 2007-11-19
Country / jurisdiction: United States
Risk level: Class II
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. GE OEC recalled imaging devices OEC 9900, OEC 9800, and OEC 8800 as a result of an FDA inspection identifying that the vertical lift column power supply in the mainframe C-arm is defective and subject to early life failure.

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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