| Date Initiated by Firm | September 02, 2004 |
|---|
| Date Posted | January 11, 2006 |
|---|
| Recall Status1 |
Terminated 3 on January 05, 2007 |
| Recall Number | Z-0387-06 |
|---|
| Recall Event ID |
33266 |
| 510(K)Number | K014206 |
|---|
| Product Classification |
System, Imaging, Pulsed Doppler, Ultrasonic - Product Code IYN
|
| Product | LOCIQ Book System models: 2399921, 2399923, 2349933, 2349934 and 2349935 |
|---|
| Code Information |
all serial numbers |
| FEI Number |
2126677
|
Recalling Firm/
Manufacturer |
General Electric Med Systems LLC
3000 N Grandview Blvd
Waukesha WI 53188-1615
|
Manufacturer 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. |
|---|
FDA Determined
Cause 2 | Other |
|---|
| Action | 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. |
|---|
| Quantity in Commerce | 2698 |
|---|
| Distribution | nationwide and worldwide |
|---|
| Total Product Life Cycle | TPLC Device Report |
|---|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
| 510(K) Database | 510(K)s with Product Code = IYN
|
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