Siemens Artis zee X-ray Systems Recalled for Collimator Filter Dislocation
Siemens Medical Solutions is recalling 17 Artis zee X-ray systems because a scatter radiation filter inside the card collimator may dislocate.
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 medical device with a potential mechanical defect that could affect radiation safety, but the source text does not report any injuries, illnesses, or fatalities, placing it in the 'risk-of-harm products where injury has not yet been reported' category.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 17 Artis zee systems X-ray, angiographic systems. The affected units are model numbers 10094135, 10094137, and 10094141 equipped with a card collimator from a specific lot.
The recall was initiated because a dislocation of the scatter radiation filter inside the card collimator may occur. This potential issue was identified by the firm.
The affected devices were distributed in the United States, including the states of Arizona, Kentucky, Pennsylvania, Iowa, West Virginia, Florida, Missouri, Oklahoma, California, Arkansas, Montana, New York, Kansas, and Connecticut.
The recalled product
- Product
- Artis zee systems x-ray, angiographic system
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Category
- Medical Device — X-ray System
- Affected units
- 17
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 numbers 10094135
- 10094137
- and 10094141 equipped with a card collimator from a specific lot
Distribution
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