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FDAOctober 30, 2015device

Artis systems with large display from Siemens Medical Solutions USA, Inc. Interventional Fluoroscopic X-ray for angiographic procedures.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Due to improper soldering in a limited number of large display bypass module components of a specific production lot, a loss of video signal could potentially occur. This has not been observed in the field and only sporadic cases have been observed in factory screening.

What to do

FDA enforcement status: Terminated

Brands named

siemens medical solutionssiemenssiemens medical

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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