FDA Medical Device Recalls (openFDA)
GE OEC Medical Systems, Inc: OEC MiniView 6800. The Mini 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.
- Recall number
- Z-0193-2015
- Recalling firm
- GE OEC Medical Systems, Inc
- Product
- OEC MiniView 6800. The Mini 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.
- Status
- Terminated
- Initiated
- 2014-10-03
- Posted
- 2014-11-07
- Terminated
- 2015-03-23
- Reason
- GE Healthcare initiated a field correction because prior revision of components were potentially installed on certain OEC 9800, FlexiView 8800, OEC MiniView 6800 and OEC UroView 2800 systems.
- Root cause
- Component design/selection
- Action
- On October 3. 2014. GE Healthcare Surgery began distributing an Urgent Medical Device Correction letter to customers to inform them of the issue and provide instructions for immediate mitigation of the issue. The letter was sent to 3 titles at each facility affected: 1.1 Facility Administrator. 2.1 Director/Manager of Radiology and Radiologists, 3.) Radiology Department. Firm will track all service requests for the field action to completion. These service requests will document the inspection and component replacement (if applicable) on the affected units. Exceptions to completion of the service request will be recorded. Records of field action completion will be retained per our processes and procedures. No product is being returned.
- Quantity
- 26
- Distribution
- Worldwide Distribution.
- Lot, serial or model codes
- Serial No: 86-0039,86-0135,86-0191,86-0318,86-0334,86-0587,86-0611,86-0619,86-0758,86-0782,86-0931,86-0935-RC,86-1129,86-1220,86-1241,86-1376,86-1432,86-1503,86-1551,86-1614,86-1678,86-1702,86-1736,86-1959,86-2092,86-2119
- 510(k) numbers
- ["K992506"]
- PMA numbers
- not on file
- Product code
- OXO
- Firm FEI
- 1720753
- Firm city
- Salt Lake City
- Firm state
- UT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28