OEC FlexiView 8800, Digital Mobile Imaging System, GE Medical Systems
FDA device recall Z-1469-2017 · posted 2017-02-27 · Terminated
Recall details
- Recalling firm
- GE OEC Medical Systems, Inc
- Reason for recall
- OEC FlexiView 8800 workstation power cable assembly issue which can result in a loss of imaging functionality due to intermittent power cord failures.
- Action taken
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- OXO
- Quantity affected
- 1
- Distribution
- One consignee in CA.
- Date initiated
- 2017-02-21
- Date posted
- 2017-02-27
- Date terminated
- 2017-04-24
- Location
- Salt Lake City, UT
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| FLEXIVIEW 8800 DIGITAL MOBILE IMAGING SYSTEM (K003837) | Ge Oec Medical Systems | 2001-03-12 |