Siemens Artis zeego X-ray Systems Recalled for Mechanical and Electrical Defects
Siemens is recalling 552 Artis zeego angiography systems due to risks of mechanical cable damage and high-voltage generator module failure.
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 high-risk medical device with mechanical and electrical defects that could lead to equipment failure, but the source text does not report any injuries, illnesses, or deaths, placing it in the 'High' category per the rubric.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 552 units of the Artis zeego angiography system, including models 10094135, 10094137, 10094139, 10094141, and 10280959. These dedicated angiography systems are used for single and biplane diagnostic imaging and interventional procedures, including those for pediatric and obese patients.
The recall is due to two specific defects. First, in Artis zeego systems, angulations near the C-arm collision area can cause the cable inlet to become clamped, resulting in mechanical damage. Second, in Artis systems equipped with A100Plus generators, attempting to resume operation after a fault detection (such as a short circuit in the X-ray tube) can cause a module in the high-voltage generator to fail.
The affected units were distributed nationwide across the United States, including all 50 states, the District of Columbia, Puerto Rico, and the U.S. Virgin Islands. Healthcare facilities and users of these systems should contact Siemens Medical Solutions USA, Inc. for further instructions on how to address these defects.
The recalled product
- Product
- system, x-ray, angiographic, model # 10094135, 10094137, 10094139, 10094141, 10280959 Artis zee/ zeego is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and ob
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Affected units
- 552
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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