| Date Initiated by Firm | July 14, 2015 |
|---|
| Date Posted | August 05, 2015 |
|---|
| Recall Status1 |
Terminated 3 on March 03, 2016 |
| Recall Number | Z-2338-2015 |
|---|
| Recall Event ID |
71712 |
| 510(K)Number | K123737 |
|---|
| Product Classification |
System, tomography, computed, emission - Product Code KPS
|
| Product | Biograph 64-3R TruePoint w/ TrueV, Model Number 10097301 |
|---|
| Code Information |
SERIAL NUMBER 1020 |
Recalling Firm/
Manufacturer |
Siemens Medical Solutions USA Inc.
810 Innovation Dr
Knoxville TN 37932-2562
|
| For Additional Information Contact | Service representatives
865-218-2000 |
|---|
Manufacturer Reason
for Recall | Emission computed tomography systems and computed tomography xray systems with optional ceiling mounts may be missing a locking ring. |
|---|
FDA Determined
Cause 2 | Packaging change control |
|---|
| Action | The firm initiated their recall on 07/14/2015 by telephone to the sole US consignee. The update is scheduled for 07/15/2015. |
|---|
| Quantity in Commerce | 1 unit |
|---|
| Distribution | Distributed in the state of Texas and the countries of Germany, France, Russia, Denmark, 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 = KPS
|
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