Siemens Artis Zee Angiographic Systems Recalled for Cable Connection Defect
Siemens Medical Solutions is recalling nine Artis Zee Angiographic x-ray systems due to an inappropriate cable connection that may cause system failure and restricted gantry maneuverability.
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 defect that may cause system failure and restricted maneuverability, representing a risk of harm where injury has not yet been reported, consistent with the High severity criteria.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling nine Artis Zee Angiographic x-ray systems. The recall involves specific model numbers: 10094135, 10094137, 10094139, 10094141, and 10280959.
The recall was initiated because an inappropriate cable connection was assembled for these systems. This defect may cause a system failure and possibly lead to restricted maneuverability of the gantry system.
The affected units were distributed in Minnesota, Wisconsin, Pennsylvania, Michigan, Alabama, Ohio, North Carolina, Arkansas, and New Jersey. Healthcare facilities should contact Siemens Medical Solutions USA, Inc. for instructions on how to address the cable connection issue.
The recalled product
- Product
- Artis Zee Angiographic x-ray systems.
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Affected units
- 9
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 (5)
- Model numbers: 10094135
- 10094137
- 10094139
- 10094141
- 10280959.
Distribution
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