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

FDA device recall Z-2240-2012 · posted 2012-08-22 · Terminated

Recall details

Recalling firm

GE OEC Medical Systems, Inc

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.

Action taken

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.

Root cause

Device Design

Status

Terminated

Product code

JAA

Quantity affected

3,595 units

Distribution

Worldwide Distribution -- USA (nationwide)

Date initiated

2009-11-06

Date posted

2012-08-22

Date terminated

2013-01-28

Location

Salt Lake City, UT

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