Recall Z-1469-2017 ยท OXO Image-Intensified Fluoroscopic X-Ray System, Mobile
GE OEC Medical Systems, Inc
OEC FlexiView 8800, Digital Mobile Imaging System, GE Medical Systems
| Date | Feb 27, 2017 (initiated Feb 21, 2017) |
| Status | Terminated |
| Reason | OEC FlexiView 8800 workstation power cable assembly issue which can result in a loss of imaging functionality due to intermittent power cord failures. |
| Root cause | Process control |
| Action | On February 21, 2017, an Urgent Medical Device Correction letter was sent to one consignee with an affected unit; a field service representative hand delivered the customer communication. |
| Quantity | 1 |
| Distribution | One consignee in CA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K003837 | FLEXIVIEW 8800 DIGITAL MOBILE IMAGING SYSTEM Ge Oec Medical Systems, Mar 12, 2001 |