Food, drugs, devices › GE OEC Medical Systems, Inc
Device recall: OEC 9800. MDL Numbers: D222250, D141598
FDA enforcement event 76074 is a device recall by GE OEC Medical Systems, Inc of Salt Lake City, UT, initiated 27 Dec 2016 and classified Class II, with 2 product records.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 91% of the 1,232 device enforcement events initiated in 2016 carry the same class.
Status: Terminated, terminated 12 Jul 2018. Initiation: voluntary: firm initiated. GE OEC Medical Systems, Inc has 28 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
GE OEC Medical Systems, Inc, Salt Lake City, UT.
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."
Distribution
"Worldwide including govt/VA/military and foreign consignees."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1059-2017 | OEC 9800. MDL Numbers: D222250, D141598 | 26,256 total | Class II | Terminated | 1 Feb 2017 |
| Z-1060-2017 | OEC 9900 Elite. MDL Numbers: D148942, D155043 | 26,256 total | Class II | Terminated | 1 Feb 2017 |
Context
Other enforcement events for GE OEC Medical Systems, Inc
All 28 events for GE OEC Medical Systems, Inc
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide including govt/VA/military and foreign consignees."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 12 Jul 2018. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.