| Date Initiated by Firm | May 12, 2003 |
|---|
| Date Posted | June 21, 2003 |
|---|
| Recall Status1 |
Terminated 3 on July 07, 2011 |
| Recall Number | Z-0945-03 |
|---|
| Recall Event ID |
26383 |
| 510(K)Number | K893475 K914446 |
|---|
| Product Classification |
System, X-Ray, Fluoroscopic, Image-Intensified - Product Code JAA
|
| Product | Uroview 2000 X-ray System |
|---|
| Code Information |
Serial numbers beginning with T2 and T9 |
| FEI Number |
1720753
|
Recalling Firm/
Manufacturer |
GE OEC Medical Systems,Inc
384 Wright Brothers Drive
Salt Lake City UT 84116
|
| For Additional Information Contact |
801-536-4668 |
|---|
Manufacturer Reason
for Recall | Uncommanded motion of the urological table is possible should the hand control assembly be exposed to liquids. |
|---|
FDA Determined
Cause 2 | Other |
|---|
| Action | A Product Safety Alert letter was sent to all consignees on 5/12/2003 recommending that all hand controls be removed from the units. |
|---|
| Quantity in Commerce | 211 units |
|---|
| Distribution | Nationwide. Foreign distribution to Argentina, Australia, Austria, Canada, Germany, Italy, Japan, Mexico, Russia and Switzerland. |
|---|
| 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 = JAA
|
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