GE OEC Medical Systems, Inc: Medical Device Recall in 2012 - (Recall #: Z-2240-2012)

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:

892.1650 Image-intensified fluoroscopic x-ray system; the device is designed to provide fluoroscopic and spot film imaging of the patient during diagnostic surgical and interventional procedures. The systems include features specifically designed for use in diagnostic and interventional cardiac imaging procedures, and are also intended for cholangiography, endoscopic, urologic, orthopedic, neurologic, vascular, critical care and emergency room procedures. The systems may be used for other imaging applications at the physician's discretion.

Product Classification:

Class II

Date Initiated: November 6, 2009

Date Posted: August 29, 2012

Recall Number: Z-2240-2012

Event ID: 62691

Reason for Recall:

GE OEC is recalling certain 9800 Image Intensified Flouroscopic x-ray systems due to customer complaint analysis showing that a replacement Hitachi 160 GB Hard Drive, when installed on certain models is susceptible of causing unanticipated system shut downs, no boots, data loss or data mix, or unexpected hard drive corruption.

Status: Terminated

Product Quantity: 3,595 units

Code Information:

Model Number HDS721616PLAT80; GE Healthcare part number 5304649.

Distribution Pattern:

Worldwide Distribution -- USA (nationwide)

Voluntary or Mandated:

Voluntary: Firm initiated