GE Healthcare Voluson E8 ultrasound scanner with Software version 6.2.0 and 6.2.1 and DICOM stations with these software
FDA device recall Z-0113-2008 · posted 2007-11-07 · Terminated
Recall details
- Recalling firm
- Ge Healthcare
- Reason for recall
- When a spectrum of a Pulsed Wave Doppler shows an angle correction unequal to 0 is reloaded from the archive or the image is sent to a DICOM station, this angle correction is mistakenly disregarded resulting in an underestimation of the flow velocities.
- Action taken
- GE Healthcare sent customer letters on July 15, 2007 to affected customers. The letter included a short term mitigation recommendation and a long-term correction. The long-term correction will be software upgrade provided free of charge to all affected customers.
- Root cause
- Software design
- Status
- Terminated
- Product code
- IYO
- Quantity affected
- 521 Units
- Distribution
- Nationwide.
- Date initiated
- 2007-07-06
- Date posted
- 2007-11-07
- Date terminated
- 2008-10-21
- Location
- Wauwatosa, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GE VOLUSON E8 ULTRASOUND SYSTEM (K061682) | General Electric Co. | 2006-07-12 |