LOGIQ 5 system models 2331752, 2331753, 2332750, 2353313 and 2355477.
FDA device recall Z-0386-06 · posted 2006-01-11 · Terminated
Recall details
- Recalling firm
- General Electric Med Systems LLC
- Reason for recall
- The Estimated Fetal Weight (EFW) result will be incorrect if the operator fails to perform the 'end exam' or new patient registration step before starting an EFW measurement procedure on the next patient.
- Action taken
- Devices will have software upgrades done by GE Field Service Technicians. The upgrade will include a dialog box which will display on the screen when prior data exists and a new patient is being registered.
- Root cause
- Other
- Status
- Terminated
- Product code
- IYN
- Quantity affected
- 393
- Distribution
- nationwide and worldwide
- Date initiated
- 2004-09-02
- Date posted
- 2006-01-11
- Date terminated
- 2007-01-05
- Location
- Waukesha, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GE LOGIQ 5 (K014097) | GE Medical Systems | 2002-01-10 |