Interventional Fluoroscopic X-Ray System ARTIS icono biplane- 11327600 ARTIS icono floor- 11327700 ARTIS pheno- 10849000 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.
Reported: May 5, 2021 Initiated: March 19, 2021 #Z-1497-2021
Product Description
Interventional Fluoroscopic X-Ray System ARTIS icono biplane- 11327600 ARTIS icono floor- 11327700 ARTIS pheno- 10849000 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.
Reason for Recall
Siemens has become aware of a potential issue with software version VE20C. Planned procedures may have to be terminated and performed on an alternative x-ray system.
Details
- Recalling Firm
- Siemens Medical Solutions USA, Inc
- Units Affected
- 133 systems
- Distribution
- Worldwide distribution: US (nationwide) including states of: CA, CO, DE, FL, IL, IN, KY, MD, MI, NC, NE, NJ, NY, OH, TN, TX, UT, WI, and OUS (countries) of: AT, BE, ES, IT, FI, CH, FR, GB, SE, DE, DK, IE and NL.
- Location
- Malvern, PA
Frequently Asked Questions
What product was recalled? ▼
Interventional Fluoroscopic X-Ray System ARTIS icono biplane- 11327600 ARTIS icono floor- 11327700 ARTIS pheno- 10849000 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.. Recalled by Siemens Medical Solutions USA, Inc. Units affected: 133 systems.
Why was this product recalled? ▼
Siemens has become aware of a potential issue with software version VE20C. Planned procedures may have to be terminated and performed on an alternative x-ray system.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 5, 2021. Severity: Moderate. Recall number: Z-1497-2021.
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