FDAFDA · Food and drugs·Recall number Z-1060-2017
OEC 9900 Elite. MDL Numbers: D148942, D155043
Published February 1, 2017 · Recall initiated: December 27, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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 to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- GE OEC Medical Systems, Inc
- Distributor
- Worldwide including govt/VA/military and foreign consignees.
- Lot
- Manufactured from Oct 2005 to present
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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