| Date Initiated by Firm | January 21, 2011 |
|---|
| Date Posted | January 11, 2012 |
|---|
| Recall Status1 |
Terminated 3 on August 13, 2012 |
| Recall Number | Z-0396-2012 |
|---|
| Recall Event ID |
60440 |
| Product Classification |
Table, operating-room, ac-powered - Product Code FQO
|
| Product | OR table TITAN T, Surgical Table.
Surgical bed with Orthopedic Accessories. |
|---|
| Code Information |
Material number: 197903, All Serial numbers. |
| FEI Number |
3003184737
|
Recalling Firm/
Manufacturer |
Trumpf Medical Systems, Inc.
415 Jessen Ln
Charleston SC 29492
|
| For Additional Information Contact | Lindsey Ronneberg
843-822-6939 |
|---|
Manufacturer Reason
for Recall | Product is being recalled due to unintended movement on the Titan Tables. |
|---|
FDA Determined
Cause 2 | Device Design |
|---|
| Action | Trumpf Medical Systems sent an initial notification to customers dated January 24, 2011. A subsequent "URGENT SAFETY NOTICE-UPDATE" letter dated May 26, 2011 was sent to all affected customers. The letter described the product, problem, and actions to be taken by the customers. A Corrective Action Plan includes a software update to be installed by a Trumpf Technical Service Representative. Contact Technical Service at 888-474-9359 for questions regarding this notice. |
|---|
| Quantity in Commerce | see line 1. |
|---|
| Distribution | Worldwide Distribution. |
|---|
| 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.
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