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Siemens AG/Siemens Healthcare Recalls

3 recalls on record · July 10, 2024 to July 10, 2024 · Medical Devices

July 10, 2024Medical DevicesFDA
Siemens AG/Siemens Healthcare GmbH recalls ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventiona
Hazard: 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.
July 10, 2024Medical DevicesFDA
Siemens AG/Siemens Healthcare GmbH recalls ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventiona
Hazard: 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.
July 10, 2024Medical DevicesFDA
Siemens AG/Siemens Healthcare GmbH recalls ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventiona
Hazard: 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.
Siemens AG/Siemens Healthcare Recalls | RecallWatchUSA