Recall Z-2241-2024— Siemens AG/Siemens Healthcare GmbH
Class II · Ongoing
Class II FDA medical device recall by Siemens AG/Siemens Healthcare GmbH, initiated 2024-06-26. It names one FDA 510(k) clearance: K221516. Product: ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.. Reason: 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..
- Recalling firm
- Siemens AG/Siemens Healthcare GmbH
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-06-26
- Firm location
- Forchheim, N/A, Germany
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.