Siemens AG/Siemens Healthcare GmbH: ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to,

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.

Details from the source

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. Distribution: Worldwide - US Nationwide distribution in the states of TX, MA, NH, MN, OK, NJ, SC, NY, MI, IL, MO, NC. Quantity: 201 units in total Lot/code info: ARTIS icono biplane 11327600 4056869063317 ARTIS icono ceiling 11328100 4056869295923 ARTIS icono floor 11327700 4056869149325

UPC codes

4056869063317, 4056869295923, 4056869149325

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.