Siemens AG/Siemens Healthcare GmbH: Device Recall

Recall Details

Recall Number

Z-2241-2024

Classification

Class II

Product Type

Device

Recalling Firm

Siemens AG/Siemens Healthcare GmbH

Status

Ongoing

Date Initiated

06/26/2024

Location

Forchheim, N/A, Germany

Voluntary/Mandated

FDA Mandated

Product Quantity

201 units in total

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.

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.

Distribution Pattern

Worldwide - US Nationwide distribution in the states of TX, MA, NH, MN, OK, NJ, SC, NY, MI, IL, MO, NC.

Other Recalls by Siemens AG/Siemens Healthcare GmbH

• Class II: Risk 06/26/2024
  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.
• Class II: Risk 06/26/2024
  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.

View all recalls by Siemens AG/Siemens Healthcare GmbH →