FDA Medical Device Recalls (openFDA)
GE OEC Medical Systems, Inc: 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.
- Recall number
- Z-2240-2012
- Recalling firm
- GE OEC Medical Systems, Inc
- Product
- 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.
- Status
- Terminated
- Initiated
- 2009-11-06
- Posted
- 2012-08-22
- Terminated
- 2013-01-28
- Reason
- 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.
- Root cause
- Device Design
- Action
- GE OEC sent a Urgent Recall Notice dated November 6, 2009, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The notification advised them that GE Healthcare had identified a potential safety issue associated with a "Significant increase on Data Loss, Data Mix, and System file corruption of the Hard Drives" on the 9800 Systems. The field correction consisted of installing a "Smart Power Switch" between the power control PCB and the system power switch on 9800 Systems with a Celeron single board computer and software version 29. This will remedy the potential for data loss, data mix, and system file corruption of the hard drives. For further questions please call 800-874-7378 Option 8.
- Quantity
- 3,595 units
- Distribution
- Worldwide Distribution -- USA (nationwide)
- Lot, serial or model codes
- Model Number HDS721616PLAT80; GE Healthcare part number 5304649.
- 510(k) numbers
- ["K021049","K022069","K024012"]
- PMA numbers
- not on file
- Product code
- JAA
- Firm FEI
- 1720753
- Firm city
- Salt Lake City
- Firm state
- UT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28