GE LightSpeed CT750 HD The GE LightSpeed CT750 HD Computed Tomography X-ray system is intended to produce cross-sectiona
FDA device recall Z-1940-2013 · posted 2013-08-09 · Terminated
Recall details
- Recalling firm
- GE Healthcare, LLC
- Reason for recall
- GE Healthcare conducted a recall involving 2 events affecting the GE LightSpeed CT750 HD. Event 1 - There was a report regarding CT number variance in time line at posterior fossa region of head perfusion. When beam hardening and helical artifacts in this region are reconstructed into the perfusion map, these artifacts will give subtle differences in the CT numbers. Event 2 - The software does no
- Action taken
- GE Healthcare's recall strategy was to update CT750HD CT Systems with software 10MW25.6 on all systems that were distributed. Updates started on 4/5/2011. At this time, deployment of this recall is considered complete. The recall was completed 2/2/2012. Should you have any questions or require additional information, please contact Regulatory Affairs Leader by telephone at 262-548-2198 or email paulcorrigan@ge.com.
- Root cause
- Software design
- Status
- Terminated
- Product code
- JAK
- Quantity affected
- 244
- Distribution
- Worldwide distribution: US (nationwide) including states of: AL, AZ, CA, CT, FL, GA, HI, IL, IN, IA, KY,ME, MD,MA, MI,MN, MS, NV, NH, NJ, NY, NC, PA, TN, TX, VA, WA,WV, and WI; and countries of: AUSTR
- Date initiated
- 2011-04-05
- Date posted
- 2013-08-09
- Date terminated
- 2014-08-11
- Location
- Waukesha, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GE LIGHTSPEED CT750 HD (LIGHTSPEED 8.0) (K081105) | GE Healthcare | 2008-05-09 |