The OEC 9900 C-Arm is designed to provide fluoroscopic and… recallZ-2872-2020 · Ge Healthcare · initiated May 8, 2020
Class II Open, Classified All recalls posted in August 2020
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 Healthcare 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
GEHC Surgery became aware that some users of the 9800 and 9900 fluoroscopic mobile C-Arms (referred to as the system here on) within the United States had requested that a Field Service Engineer (FSE) change the dose value on the live update screen from AKR / CAK to DAP. All systems sold to customers in the US that leave GEHC Surgery (the place of manufacture) are configured to display AKR / CAK when they leave the factory. An FSE changing the dose display, per the customer request, to display DAP instead does not comply to 21CFR 1020.32(k), which requires fluoroscopic equipment manufactured on or after June 10, 2006 to display continuous updates of AKR and CAK values.
FDA root cause category: Radiation Control for Health and Safety Act
Recall details
- Recall number
- Z-2872-2020
- Recall class
- Class II
- Status
- Open, Classified
- Initiated by the company
- May 8, 2020
- Posted by the FDA
- Aug 27, 2020
- Recalling firm
- Ge Healthcare
- Quantity
- 221
- Product code
- RCC
- FDA submissions
- K111551, K120613, K122234, K132027
- Distribution
- Nationwide
Product description
The OEC 9900 C-Arm is designed to provide fluoroscopic and spot-film images of the patient during diagnostic, surgical and interventional procedures. Examples of clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, critical-care and emergency room procedures. The GE OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. The system includes features specifically designed for use in diagnostic and interventional cardiac imaging procedures, and is also intended for cholangiography, endoscopic, urologic, orthopedic, neurologic, vascular, critical care and emergency room procedures.
Code information (models, lots, serial numbers)
OEC 9800, OEC 9900 Elite
Other devices under the same FDA submission
1 device cleared under K111551, K120613, K122234, K132027 — 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.
How recalls are matched to devices · Editorial policy · Report an error on this page