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

Recall Z-1059-2017 — OEC 9800. MDL Numbers: D222250, D141598

U.S. FDA — Device Enforcement · United States · 2016-12-27 · Class II

AI-assisted, human-edited — this page is drafted with AI from public-source data, then reviewed before publication. How we use AI →
Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1059-2017
Date of alert
2016-12-27
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: GE Healthcare Surgery announces a voluntary field action for the OEC 9800 and OEC 9900 Elite due to additional supplementation to the user documentation to include areas for enhanced planned maintenance and component replacement frequencies.
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.

Related

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.