GE Healthcare, LOGIQ S8 Ultrasound System The device is intended for use by a qualified physician for ultrasound evaluat
FDA device recall Z-1944-2013 · posted 2013-08-09 · Terminated
Recall details
- Recalling firm
- GE Healthcare, LLC
- Reason for recall
- GE Healthcare became aware of a potential issue related to incorrect image measurement associated with the software of the LOGIQ S8 system. This issue was found internally. Users may notice that the system shows incorrect image measurement results on Pulsed Wave (PW) or Time Intensity Curve (TIC) or depth measurement when using Virtual Convex mode and putting a cursor (Sample Volume, Depth measur
- Action taken
- GE initiated a field action on 8/13/12. GE plans to update the software on all of the affected GE LOGIQ S8 Ultrasound systems that were distributed, at no cost to the customer. Should you have any questions or require additional information, please contact RA Leader, US Region by telephone at 262-548-2089 or email James.Giles@med.ge.com.
- Root cause
- Software design
- Status
- Terminated
- Product code
- IYN
- Quantity affected
- 755
- Distribution
- Worldwide distribution: US (nationwide) including states of: AL, AZ, CA, CO, CT, DC, FL, GA, IL, IN, IA, LA, MA, MI, MS, MO, MT, NE, NV, NJ, NY, NC, OH, OK, PA,RI, SC, TN, TX, VA, WA, and WI; and coun
- Date initiated
- 2012-08-13
- Date posted
- 2013-08-09
- Date terminated
- 2014-09-15
- Location
- Waukesha, WI
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LOGIQ S8 (K111582) | GE Healthcare | 2011-07-26 |