| Date Initiated by Firm | October 01, 2006 |
|---|
| Date Posted | November 14, 2006 |
|---|
| Recall Status1 |
Terminated 3 on May 13, 2008 |
| Recall Number | Z-0168-2007 |
|---|
| Recall Event ID |
36673 |
| 510(K)Number | K033335 |
|---|
| Product Classification |
urological table - Product Code MMZ
|
| Product | Modularis URO urological table Model number 5531012 |
|---|
| Code Information |
Model number 5531012, serial numbers 01001 to 01345 |
Recalling Firm/
Manufacturer |
Siemens Medical Solutions USA, Inc
51 Valley Stream Pkwy
Malvern PA 19355-1406
|
| For Additional Information Contact | Roland Richter
610-448-4500 |
|---|
Manufacturer Reason
for Recall | Potential pinch point with the patient table |
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FDA Determined
Cause 2 | Other |
|---|
| Action | The recalling firm has issued a Customer Safety Advisory to affected customers per Update Instructions SPO23/06/S. This letter, to be inserted in the system Operator Manual, reminds customers of the potential pinch point and provides a suggestion to avoid its occurrence. |
|---|
| Quantity in Commerce | 59 units |
|---|
| Distribution | Nationwide. |
|---|
| 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 = MMZ
|
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