The OEC 9900 Elite mobile fluoroscopy system is designed to provide fluoroscopic and spot-film images of the patient dur
FDA device recall Z-0975-2017 · posted 2017-01-09 · Terminated
Recall details
- Recalling firm
- GE OEC Medical Systems, Inc
- 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.
- 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.
- Root cause
- Use error
- Status
- Terminated
- Product code
- OXO
- 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, P
- Date initiated
- 2016-12-19
- Date posted
- 2017-01-09
- Date terminated
- 2017-08-22
- Location
- Salt Lake City, UT
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| OEC 9900 ELITE (K122234) | Ge Healthcare Surgery GE Oec Medical Systems, Inc. | 2012-08-16 |
| OEC 9900 ELITE (K120613) | Ge Healthcare Surgery GE Oec Medical Systems, Inc. | 2012-04-06 |