The OEC 9900 Elite mobile fluoroscopy system is designed to… recallZ-0975-2017 · GE OEC Medical Systems, Inc · initiated Dec 19, 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 MiniView 6800, OEC 9900 Elite, and OEC 9800 because the workstation power cable assembly can result in intermittent power cord failures.
FDA root cause category: Use error
What the company is doing
GE Healthcare sent an Urgent Medical Device Correction letter dated December 19, 2016, to all affected consignees. GE informed consignees that GE will correct all affected products. If consignnes have any questions or concerns regarding this notification, please contact GE Healthcare Service at 1-800-437-1171 or their local Service Representative. For questions regarding this recall call 801-536-4952.
Recall details
- Recall number
- Z-0975-2017
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Dec 19, 2016
- Posted by the FDA
- Jan 9, 2017
- Recalling firm
- GE OEC Medical Systems, Inc
- Product code
- OXO
- FDA submissions
- K120613, K122234
- Distribution
- Worldwide Distribution - US including U.S. States: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PUERTO RICO, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and Internationally to Canada, Mexico, and Costa Rica
Product description
The OEC 9900 Elite mobile fluoroscopy system is designed to provide fluoroscopic and spot-film images of the patient during diagnostic surgical and interventional procedure. Examples of clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedure. The system may be used for other imaging applications at the physician's discretionOEC 9900 Elite. MDL Numbers: D148942, D155043
Code information (models, lots, serial numbers)
Manufactured between 1/1/16 to 11/1/16
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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