Official recall record
ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures includi (ref Z-2241-2024)
- Issuing authority
- US FDA — Medical Devices
- Alert date
- 2024-06-26
- Country of alert
- Germany
- Alert level
- Class II
- Alert type
- recall
- Brand on record
- Siemens AG/Siemens Healthcare GmbH
What the authority reported
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.
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.
Record last checked against the registry on 2026-05-31.
Other recalls from this brand
- 2024-06-26 · US FDA — Medical Devices
ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and int
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