GE Voluson E8 Ultrasound System with software versions 6.0.0, 6.0.1,6.1.0, 6.2.0, 6.2.1, 6.2.2, 6.2,3, 7.0.0, and 7.01.
FDA device recall Z-2404-2008 · posted 2008-09-22 · Terminated
Recall details
- Recalling firm
- GE Healthcare
- Reason for recall
- Inaccurate dimension measurements in M-Mode when pan-Zoom is activated in GE Voluson E8 Ultrasound Systems. Of particular concern are potential inaccuracies of fetal cardiac measurements that may impact patient safety.
- Action taken
- Consignees were sent a GE "Urgent Medical device Correction" letter dated April 1, 22008. The letter was addressed to Healthcare Administrator/Risk Manger; Chief of Intensive Care and Director of Clinical Engineering. The letter described the safety issue; affected product details; safety instructions stating that use of the system may be continued and measurements may be made safely in M-Mode by using HD-Zoom rather than pan-Zoom; product correction stating that a GE Healthcare Rep will contact consignees in the future to schedule software updates to resolve the issue at no charge; and contact information.
- Root cause
- Software design
- Status
- Terminated
- Product code
- IYO
- Quantity affected
- 1637
- Distribution
- Worldwide Distribution --- USA including states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV,NY, OH, OK, OR, PA, RI, SC
- Date initiated
- 2008-04-01
- Date posted
- 2008-09-22
- Date terminated
- 2011-12-11
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GE VOLUSON E8 ULTRASOUND SYSTEM (K061682) | General Electric Co. | 2006-07-12 |