Siemens Artis zee and zeego X-ray Systems Recalled for Radiation Release Issue
Siemens is recalling 206 Artis zee and Artis zeego X-ray systems because radiation release can become blocked unnecessarily under certain circumstances.
What this means for you
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 medical device with a functional defect that could lead to unintended radiation exposure or operational failure, fitting the 'High' category for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 206 Artis zee and Artis zeego X-ray, angiographic systems. The recall affects systems running software version VC21B that are used in conjunction with the Large Display.
The recall is due to a potential problem where, under certain circumstances, the release of radiation can become blocked unnecessarily. The affected units have running software version VC21B with specific code numbers (10094135, 10094137, 10094141, 10280959) and multiple serial numbers.
The affected products were distributed nationwide. The source text does not specify further actions for consumers or healthcare providers beyond the identification of the defect.
The recalled product
- Product
- Artis zee and Artis zeego systems. x-ray, angiographic system
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Category
- Medical Device — X-ray Systems
- Affected units
- 206
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 (4)
- running software version VC21B 10094135
- 10094137
- 10094141
- 10280959 with multiple serial numbers .
Distribution
Distributed nationwide across the United States.
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