OEC 9900 Elite. MDL Numbers: D148942, D155043
FDA device recall Z-1060-2017 · posted 2017-01-20 · Terminated
Recall details
- Recalling firm
- GE OEC Medical Systems, Inc
- 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.
- Action taken
- The customer communication is expected to begin distribution in January 2017. Consignees will be notified of the availability of the Operator Manual supplement via a letter. No product is being returned.
- Root cause
- Packaging change control
- Status
- Terminated
- Product code
- OWB
- Quantity affected
- 26,256 total
- Distribution
- Worldwide including govt/VA/military and foreign consignees.
- Date initiated
- 2016-12-27
- Date posted
- 2017-01-20
- Date terminated
- 2018-07-12
- Location
- Salt Lake City, UT
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| OEC 9900 ELITE (K122234) | Ge Healthcare Surgery GE Oec Medical Systems, Inc. | 2012-08-16 |
| OEC 9900 ELITE (K120613) | Ge Healthcare Surgery GE Oec Medical Systems, Inc. | 2012-04-06 |