The Recall Desk
SevereFDA (Devices)·Z-0108-2021·Announced 2020-10-21

Siemens Artis zee and Q Systems Recalled for Collision Risk

Siemens Medical Solutions is recalling Artis zee and Artis Q systems because a software defect may cause the equipment to collide with room fixtures or patients.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The source text explicitly describes a risk of 'crushing of patients, operators or staff' and 'collision of system parts with patients,' which constitutes significant injury reports or potential for severe harm, meeting the criteria for a Severe (4) rating.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling specific Artis zee and Artis Q systems used for diagnostic imaging and interventional procedures. The recall involves 124 units distributed nationwide in the United States.

The recall is due to a potential software defect where the collision supervision feature may not work properly if individual room configuration data settings are lost. This malfunction creates a danger of the system colliding with fixed room equipment, walls, or the floor. Such a collision could cause system components to fall or tilt, potentially resulting in the crushing of patients, operators, or staff, or causing the system parts to collide with patients. Additionally, the issue may lead to the delay or interruption of clinical procedures.

Healthcare facilities should contact Siemens Medical Solutions USA, Inc. for instructions on how to address the issue. The source text does not specify a specific action for consumers, as these are professional medical devices.

The recalled product

Product
Artis zee or Artis Q systems (listed below) - Product Usage: for single and biplane diagnostic imaging and interventional procedures. System Name/Material Number: Artis Q BIPLANE 10848282 ARTIS Q CEILING 10848281 Artis Q floor 10848280 ARTIS Q ZEEGO 10848283 ARTIS Q.ZEN B
Affected units
124

Distribution

Distribution scope not specified by the agency.

Same manufacturer · Siemens Medical Solutions USA, Inc

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