Z-2240-2012Class II

892.1650 Image-intensified fluoroscopic x-ray system; the device is designed to provide fluoroscopic and spot...

Name: Z-2240-2012 892.1650 Image-intensified fluoroscopic x-ray system; the device is designed to provide fluoroscopic and spot...
Creator: GE OEC Medical Systems, Inc
Published: 2009-11-06
License: https://open.fda.gov/license/

GE Healthcare / initiated 2009-11-06 / Terminated / root cause: design

FDA source

GE OEC Medical Systems, Inc began a recall of 892.1650 Image-intensified fluoroscopic x-ray system; the device is designed to provide fluoroscopic and spot film imaging of the patient during diagnostic... on 2009-11-06. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2240-2012
Classification: Class II
Status: Terminated
Initiated: 2009-11-06
Posted: 2012-08-22
Terminated: 2013-01-28
Recalling firm: GE Healthcare
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.
Product code: JAA System, X-Ray, Fluoroscopic, Image-Intensified
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.
Root cause tag: design
FDA 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 in commerce: 3,595 units
Distribution: Worldwide Distribution -- USA (nationwide)
Product codes and lots: Model Number HDS721616PLAT80; GE Healthcare part number 5304649.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2240-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2240-2012	Class II	Terminated	Voluntary: Firm initiated	2012-08-29	2012-08-22

Product code JAA

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)