Z-1497-2021 Class II Terminated
FDA device recall Z-1497-2021 was initiated by Siemens Medical Solutions USA, Inc on March 19, 2021 and is designated Class II. 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. The recall status is terminated (terminated November 9, 2021). Affected quantity: 133 systems.
Recall Details
- Product Type
- Devices
- Report Date
- May 5, 2021
- Initiation Date
- March 19, 2021
- Termination Date
- November 9, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 133 systems
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.
Distribution Pattern
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.
Code Information
Software VE20C serial #s 180062 170319 180317 180072 180060 180048 180083 180315 170305 180080 180301 180305 180330 170307 180040 180333 170309 170310 170304 180316 180334 170025 180047 180085 180331 180321 180309 170312 180323 164703 170303 180329 180015 180014 180037