| Date Initiated by Firm | October 26, 2010 |
|---|
| Date Posted | December 22, 2010 |
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| Recall Status1 |
Terminated 3 on March 20, 2012 |
| Recall Number | Z-0802-2011 |
|---|
| Recall Event ID |
57209 |
| Product Classification |
Ac-Powered Operating-Room Table - Product Code FQO
|
| Product | klinoPORT, AC powered Operating Table |
|---|
| Code Information |
Model number: klinoPORT 706, 806, 906, 1006 and 1306, Serial number between: 101039290 and 101158669 |
Recalling Firm/
Manufacturer |
Kreuzer Gmbh & Co. KG
BenzstraBe 26
Puchheim Germany
|
| For Additional Information Contact | Lindsey Raonnenberg
843-416-1376 |
|---|
Manufacturer Reason
for Recall | The motorized adjustable pendant arm may suddenly descend to its lowest position. |
|---|
FDA Determined
Cause 2 | Other |
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| Action | Consignees were notified by a Warning Notice on/about 10/26/2010. Medical facilities were instructed to adjust the pendant arm to the lowest height position and disable the motor and to place the accompanying warning label on the pendant. They will, therefore, not be able to adjust the height of the pendant until corrective action is developed and completed. TRUMPF Medical Systems, Inc. will receive corrective action repair kits by 11/12/2010. |
|---|
| Quantity in Commerce | 15 units |
|---|
| Distribution | Nationwide Distribution -- CT, MA, and MO. |
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| Total Product Life Cycle | TPLC Device Report |
|---|
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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.
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