Recall Z-0974-2017
GE OEC Medical Systems, Inc · initiated December 19, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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
Codes / lots: Manufactured between 1/1/16 to 11/1/16
Reason for recall
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.
FDA-determined cause: Use error
Action taken
GE Healthcare sent an Urgent Medical Device Correction letter dated December 19, 2016, to all affected consignees. GE informed consignees that GE will correct all affected products. If consignnes have any questions or concerns regarding this notification, please contact GE Healthcare Service at 1-800-437-1171 or their local Service Representative. For questions regarding this recall call 801-536-4952.
Details
- Recall number
- Z-0974-2017
- Initiated
- December 19, 2016
- Posted by FDA
- January 9, 2017
- Terminated
- August 22, 2017
- Product code
- OXO – Image-Intensified Fluoroscopic X-Ray System, Mobile
- Distribution
- 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
- Recalling firm
- GE OEC Medical Systems, Inc, Salt Lake City, UT
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0973-2017 Class II | OEC 9800. MDL Numbers: D222250, D141598 The OEC 9800 is designed to provide fluoroscopic…GE Healthcare Surgery announces a voluntary field action for the OEC MiniView 6800, OEC 9900 Elite, and OEC… | 12/19/2016Terminated |
| Z-0975-2017 Class II | The OEC 9900 Elite mobile fluoroscopy system is designed to provide fluoroscopic and…GE Healthcare Surgery announces a voluntary field action for the OEC MiniView 6800, OEC 9900 Elite, and OEC… | 12/19/2016Terminated |