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Siemens Medical Solutions USA, Inc recalls ARTIS Pheno Model 10849000. Interventional Fluoroscopic X-Ray System Product Usage: Artis is a family of dedicated a
Recalled August 22, 2018 · FDA recall Z-2748-2018 · Siemens Medical Solutions USA
Hazard
Potential hardware issue which may cause thermal effects and possible damage to system parts. · FDA Class II
Units
605 units in total
Sold at
US Nationwide Distribution
Description
Potential hardware issue which may cause thermal effects and possible damage to system parts.
Product
ARTIS Pheno Model 10849000. Interventional Fluoroscopic X-Ray System 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. Procedures that can be performed with the Artis family include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. Artis can also support the acquisition of position triggered imaging for spatial data synthesis.
Manufacturer(s)
Siemens Medical Solutions USA, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →