Siemens Artis zee/zeego Systems Recalled for Position Sensor Fault
Siemens is recalling 475 Artis zee/zeego angiography systems because a position sensor fault could cause the system to exceed its usual speed and collide.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (potential collision) where injury has not yet been reported, which aligns with the High severity criteria in the rubric.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 475 Artis zee/zeego systems, which are dedicated angiography systems used for diagnostic imaging and interventional procedures. The recall is due to a possible position sensor fault in the swivel base axis that may not be detected by the system software.
If the fault occurs while the system is moving, it could potentially exceed its usual speed, resulting in a collision. The source text states that no injuries have been reported.
The affected units are distributed nationwide in the United States. Consumers and healthcare facilities should contact Siemens Medical Solutions USA, Inc. for instructions on how to address the defect.
The recalled product
- Product
- Artis zee/ zeego systems; Product Usage: Usage: Artis zee/ zeego systems are dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be…
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Hazard
- Affected units
- 475
Distribution
Distributed nationwide across the United States.
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