ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventiona
FDA device recall Z-2240-2024 · posted 2024-07-02 · Open, Classified
Recall details
- Recalling firm
- Siemens AG/Siemens Healthcare GmbH
- Reason for recall
- A potential issue with ARTIS icono systems equipped with a small detector and a corresponding collimator (model # 10843101) 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.
- Action taken
- Inform customers of the temporary workaround to mitigate the issue: Take any action which will lead to a change of the prefiltration prior to the first x-ray release after a patient registration. This could be the first acquisition, the change of the organ program or change to water values due to steeper angulation. This will help to avoid the occurrence of this issue. Siemens Medical Solutions will contact customers to arrange a date to distribute a software update to permanently resolve the defect.
- Root cause
- Software design
- Status
- Open, Classified
- Product code
- OWB
- Quantity affected
- 201 units in total
- Distribution
- Worldwide - US Nationwide distribution in the states of TX, MA, NH, MN, OK, NJ, SC, NY, MI, IL, MO, NC.
- Date initiated
- 2024-06-26
- Date posted
- 2024-07-02
- Location
- Forchheim, Germany
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ARTIS icono (VE21) System (K220432) | Siemens Medical Solutions USA, Inc. | 2022-06-29 |