—#183013

Product

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.

FDA product code: RCC — C-Arm Fluoroscopic X-Ray System
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K111551, K120613, K122234, K132027
Affected lot / code info: OEC 9800, OEC 9900 Elite

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.

Root cause (FDA determination)

Radiation Control for Health and Safety Act

Recalling firm

Firm: Ge Healthcare
Address: 384 Wright Brothers Dr, Salt Lake City, Utah 84116-2862

Distribution

Distribution pattern: Nationwide

Timeline

Recall initiated: 2020-05-08
Posted by FDA: 2020-08-27
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #183013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.