| Date Initiated by Firm | January 02, 2025 |
|---|
| Date Posted | January 29, 2025 |
|---|
| Recall Status1 |
Open3, Classified |
| Recall Number | Z-0922-2025 |
|---|
| Recall Event ID |
96088 |
| 510(K)Number | K133580 |
|---|
| Product Classification |
Interventional fluoroscopic x-ray system - Product Code OWB
|
| Product | ARTIS One Angiographic X-Ray System |
|---|
| Code Information |
Model Number 10848600 |
Recalling Firm/
Manufacturer |
SIEMENS MEDICAL SOLUTIONS USA, INC
40 Liberty Blvd
Malvern Germany
|
Manufacturer Reason
for Recall | A potential issue with ARTIS One systems was identified. In very
rare situations, the first x-ray release following patient registration may be performed with incorrect
copper prefiltration. If the described issue occurs, the applied radiation dose-rate may be higher
than intended by the user.
|
|---|
FDA Determined
Cause 2 | Radiation Control for Health and Safety Act |
|---|
| Quantity in Commerce | 1140 |
|---|
| Distribution | 23 Distributed in the US |
|---|
| 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
|
| 510(K) Database | 510(K)s with Product Code = OWB
|
|---|
