OEC 9900 Elite. MDL Numbers: D148942 recall
OEC 9900 Elite. MDL Numbers: D148942, D155043
Why was OEC 9900 Elite. MDL Numbers: D148942 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Manufactured from Oct 2005 to present
- Product
- OEC 9900 Elite. MDL Numbers: D148942, D155043
- Recalling firm
- GE OEC Medical Systems, Inc
- Quantity
- 26,256 total
- Distribution
- Worldwide including govt/VA/military and foreign consignees.
- Recall date
- February 1, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)