OEC 9900 Elite. MDL Numbers: D148942, D155043
Reported: February 1, 2017 Initiated: December 27, 2016 #Z-1060-2017
Product Description
OEC 9900 Elite. MDL Numbers: D148942, D155043
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.
Details
- Recalling Firm
- GE OEC Medical Systems, Inc
- Units Affected
- 26,256 total
- Distribution
- Worldwide including govt/VA/military and foreign consignees.
- Location
- Salt Lake City, UT
Frequently Asked Questions
What product was recalled? ▼
OEC 9900 Elite. MDL Numbers: D148942, D155043. Recalled by GE OEC Medical Systems, Inc. Units affected: 26,256 total.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 1, 2017. Severity: Moderate. Recall number: Z-1060-2017.
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