OEC 9800 — Class II medical device recall Z-1059-2017
Terminated recall by GE OEC Medical Systems, Inc, reported 2017-02-01. GE Healthcare Surgery announces a voluntary field action for the OEC 9800 and OEC 9900 Elite due to additional
| Recall number | Z-1059-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE OEC Medical Systems, Inc, Salt Lake City, UT, United States |
| Recall initiated | 2016-12-27 |
| Classified | 2017-01-20 |
| Reported by FDA | 2017-02-01 |
| Terminated | 2018-07-12 |
| Quantity | 26,256 total |
Product
OEC 9800. MDL Numbers: D222250, D141598
Reason for recall
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.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.