| Date Initiated by Firm | July 12, 2004 |
|---|
| Date Posted | May 11, 2005 |
|---|
| Recall Status1 |
Terminated 3 on August 02, 2011 |
| Recall Number | Z-0812-05 |
|---|
| Recall Event ID |
31057 |
| 510(K)Number | K960330 |
|---|
| Product Classification |
System, Image Processing, Radiological - Product Code LLZ
|
| Product | ENTrak Navigation and Visualization System |
|---|
| Code Information |
Axcess System Kit P/N: 1005869-001 |
| FEI Number |
1720753
|
Recalling Firm/
Manufacturer |
GE OEC Medical Systems,Inc
384 Wright Brothers Dr
Salt Lake City UT 84116-2862
|
| For Additional Information Contact | GE Healthcare Field Service
801-517-6717 |
|---|
Manufacturer Reason
for Recall | Navigation inaccuracy may result if the headset registration method is used with the Axcess System Kit. |
|---|
FDA Determined
Cause 2 | Other |
|---|
| Action | Customers were notified by letter on 07/12/04. |
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| Quantity in Commerce | 2 kits |
|---|
| Distribution | Domestic distribution: VA, CT, KY, NJ, LA, PA, TN, OK, CA. Foreign distribution to Germany. There were no military or VA facilities. |
|---|
| 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 = LLZ
|
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