OEC 9900 Elite. MDL Numbers: D148942, D155043 recallZ-1060-2017 · GE OEC Medical Systems, Inc · initiated Dec 27, 2016
Class II Terminated All recalls posted in January 2017
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from GE OEC Medical Systems, Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was 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.
FDA root cause category: Packaging change control
What the company is doing
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.
Recall details
- Recall number
- Z-1060-2017
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Dec 27, 2016
- Posted by the FDA
- Jan 20, 2017
- Recalling firm
- GE OEC Medical Systems, Inc
- Quantity
- 26,256 total
- Product code
- OWB
- FDA submissions
- K120613, K122234
- Distribution
- Worldwide including govt/VA/military and foreign consignees.
Product description
OEC 9900 Elite. MDL Numbers: D148942, D155043
Code information (models, lots, serial numbers)
Manufactured from Oct 2005 to present
Other devices under the same FDA submission
1 device cleared under K120613, K122234 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- OEC 9900 ELITEOec Medical Systems, Inc. · Interventional fluoroscopic x-ray system3 recalls0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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