Siemens Artis Biplane Systems Recalled for Ceiling Mount Defect
Siemens is recalling 265 Artis zee and Artis Q biplane systems because ceiling mount screws may not be fastened correctly.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall involves a structural defect in the ceiling mount of a medical device, which falls under the rubric criterion for structural vehicle defects or significant injury/property-damage risks, warranting a Severe rating.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 265 units of Artis zee biplane and Artis Q biplane systems. These are dedicated angiography systems used for diagnostic imaging and interventional procedures.
The recall is due to a potential defect in the ceiling mount connection. Specifically, a connection consisting of 12 screws may not have been attached and fastened according to quality standards. This issue affects the rotation unit of the device.
The affected systems were distributed nationwide in the United States. Siemens will initiate a quality inspection to ensure all screws in the rotation unit meet quality standards. Healthcare facilities should contact Siemens for instructions on how to proceed with the inspection.
The recalled product
- Product
- AArtis Q/ Q.Zen biplane Artis zee biplane Product Usage: Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Hazard
- Affected units
- 265
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 (1)
- 10094141 10848282 10848355
Distribution
Distributed nationwide across the United States.
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