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ARTIS is a family of dedicated angiography systems… recallZ-2241-2024 · Siemens AG/Siemens Healthcare GmbH · initiated Jun 26, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Siemens AG/Siemens Healthcare GmbH or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Software design

What the company is doing

Inform customers of the temporary workaround to mitigate the issue: Take any action which will lead to a change of the prefiltration prior to the first x-ray release after a patient registration. This could be the first acquisition, the change of the organ program or change to water values due to steeper angulation. This will help to avoid the occurrence of this issue. Siemens Medical Solutions will contact customers to arrange a date to distribute a software update to permanently resolve the defect.

Recall details

Recall number
Z-2241-2024
Status
Open, Classified
Initiated by the company
Jun 26, 2024
Posted by the FDA
Jul 2, 2024
Recalling firm
Siemens AG/Siemens Healthcare GmbH
Quantity
201 units in total
Product code
OWB
FDA submissions
K221516
Distribution
Worldwide - US Nationwide distribution in the states of TX, MA, NH, MN, OK, NJ, SC, NY, MI, IL, MO, NC.

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.

Code information (models, lots, serial numbers)

ARTIS icono biplane 11327600 4056869063317 ARTIS icono ceiling 11328100 4056869295923 ARTIS icono floor 11327700 4056869149325

Devices named in this recall

3 devices in the FDA device registry whose identifier appears in the recall's code information.

Other products in the same recall event

The FDA groups related products into one recall event (event 94892).

Sources and updates

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