GE OEC Medical Systems, Inc: Medical Device Recall in 2012 - (Recall #: Z-2026-2012)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product Description:

OEC 9800, OEC FluoroTrak 9800 Plus, OEC 9800 Plus, OEC 9800 MD Motorized C-arm System designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. The 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. It may be used for other imaging applications at the physician's discretion.

Product Classification:

Class II

Date Initiated: November 19, 2007

Date Posted: July 25, 2012

Recall Number: Z-2026-2012

Event ID: 62404

Reason for Recall:

Please be aware that this is not a new recall. The firm has taken action; but, due to administrative issues this recall is now being classified by the Agency. GE OEC recalled imaging devices OEC 9900, OEC 9800, and OEC 8800 as a result of an FDA inspection identifying that the vertical lift column power supply in the mainframe C-arm is defective and subject to early life failure.

Status: Terminated

Product Quantity: 11,100 units

Code Information:

Part numbers: 00-884909-01, 00-884777-01, 00-884911-01, 00-885553-01, 00-884913-01, 00-885554-01, 00-885555-01, 00-886289-01. All serial numbers.

Distribution Pattern:

Worldwide Distribution.

Voluntary or Mandated:

Voluntary: Firm initiated