FDA Device recall Z-1059-2017
OEC 9800
- FDA Device
- Class II
- terminated
- Published 2017-02-01
On 2017-02-01 the FDA classified a Class II recall of OEC 9800 by Ge Oec Medical Systems, citing 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 enhan….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1059-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-12-27 |
| Published | 2017-02-01 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Ge Oec Medical Systems |
| Distribution | VA |
Product
OEC 9800. MDL Numbers: D222250, D141598
Reason
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.
Identifiers
| code_info | Manufactured from Feb 1998 to present |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1059-2017%22
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