Siemens Artis zee X-Ray System Recalled for Collision Sensor Defect
Siemens is recalling three Artis zee Interventional Fluoroscopic X-Ray Systems because a collision sensor defect may block tabletop movement, potentially delaying or interrupting procedures.
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 where injury has not yet been reported, fitting the High severity criteria for potential procedural interruption.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling three Artis zee/ zeego Interventional Fluoroscopic X-Ray Systems (Model Number: 10094142, Software Version: VC21C). The affected units are identified by serial numbers 140422, 140423, and 140430.
The recall is due to a defect in the collision sensor. When activated, the sensor may block the movement of the floating tabletop. This malfunction could result in a delay or interruption of a medical procedure.
The affected units were distributed in Washington and Texas in the United States, as well as in Denmark. Siemens is the recalling firm. No specific instructions for consumers are provided in the source text, but the defect poses a risk to the continuity of medical procedures.
The recalled product
- Product
- Artis zee/ zeego Interventional Fluoroscopic X-Ray System, Model Number: 10094142, Software Version: VC21C
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Affected units
- 3
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Model Number: 10094142 Serial Number: 140422
- 140423
- 140430 Software Version: VC21C
Distribution
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