Siemens Artis X-Ray Systems Recalled for Electrical Contact Issues
Siemens is recalling 15 Artis X-ray systems in the US because a power distributor defect may cause electrical contact interruptions, leading to procedure termination.
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 can cause procedure termination, which is a risk-of-harm product where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 15 units of the Artis Systems (Image-Intensified Fluoroscopic X-Ray System) in the United States. The affected models include the Artis Q floor, ceiling, and biplane, as well as the Artis zee ceiling and floor systems. The recall is limited to units containing a Multi Display Manager from a specific lot.
The recall is due to a defect in the power distributor that may lead to increased electrical contact resistance or the interruption of electrical contact. This issue can result in planned procedures being terminated and requiring the patient to be moved to an alternative x-ray system to complete the procedure.
The affected units were distributed nationwide in the US. The source text does not report any injuries or illnesses associated with this defect. Healthcare facilities should identify affected units by checking the serial numbers listed in the official recall notice and contact Siemens for remediation instructions.
The recalled product
- Product
- Multi Display Manager in the Artis Systems (Image-Intensified Fluoroscopic X-Ray System) as follows: Artis Q floor Model: 10848280; Artis Q ceiling Model: 10848281; Artis Q biplane Model:10848282; Artis zee ceiling Model: 10094137; Artis zee floor Model: 1009
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Affected units
- 15
Distribution
Distributed nationwide across the United States.
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