GE Ultrasound ViewPoint 6. Product Usage: ViewPoint is intended to be used in medical practices and in clinical departme
FDA device recall Z-2098-2013 · posted 2013-08-27 · Terminated
Recall details
- Recalling firm
- GE Healthcare, LLC
- Reason for recall
- GE has recently become aware of a potential safety issue due to the incorrect calculation of the pulsatility index value (PIV) for venous flow measurements associated with obstetric reporting of the GE ViewPoint 6 system. The ViewPoint calculated Doppler PIV for veins could be incorrect. An incorrect calculation of the ductus venosus PIV could lead to false high risk for trisomy 13, 18, and 21,
- Action taken
- GE Healthcare sent An Urgent Medical Device Correction letter dated August 7, 2013 to all affected customers. The letter described the affected product, problem and instructed customers to discontinue use of venous PIV for making any and all clinical decisions. The letter informed customers that a GE service engineer will install a correction at no cost. For questions contact your local GE Healthcare Representative or call 877-644-3114 (US) and 49 (0)8153-9311-11(Europe/Asia)
- Root cause
- Software Design Change
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 225
- Distribution
- Worldwide Distribution - USA Nationwide including Puerto Rico and the countries of: ANDORRA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BRAZIL, BULGARIA, CANADA, CHILE, COLOMBIA, CZECH REPUBLIC, ESTONIA, FINLAND
- Date initiated
- 2013-08-07
- Date posted
- 2013-08-27
- Date terminated
- 2014-04-25
- Location
- Waukesha, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VIEWPOINT 6 (K103458) | GE Healthcare | 2011-03-04 |