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Recall Observatory FDA recall evidence

Device product

OEC MiniView 6800. MDL Number: D002533 The OEC MiniView 6800 Digital Mobile C-Arm is designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imaging. The device is not intended for whole-body pediatric imaging

Z-0974-2017

December 19, 2016

Class II

Product summary

Firm
GE OEC Medical Systems, Inc
Event
Event 76033
Status
Terminated
Classification
Class II
Quantity
Unavailable
Official record key
device-enforcement:Z-0974-2017

Official wording

Reason: GE Healthcare Surgery announces a voluntary field action for the OEC MiniView 6800, OEC 9900 Elite, and OEC 9800 because the workstation power cable assembly can result in intermittent power cord failures.

Code information: Manufactured between 1/1/16 to 11/1/16

Distribution pattern: Worldwide Distribution - US including U.S. States: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PUERTO RICO, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and Internationally to Canada, Mexico, and Costa Rica

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    GE Healthcare Surgery announces a voluntary field action for the OEC MiniView 6800, OEC 9900 Elite, and OEC 9800 because the workstation power cable assembly can result in intermittent power cord failures.