Class 2 Device Recall Siemens Artis Pheno

• Date Initiated by Firm: June 22, 2018
• Create Date: August 11, 2018
• Recall Status: Terminated on January 15, 2020
• Recall Number: Z-2748-2018
• Recall Event ID: 80586
• 510(K)Number: K163286
• Product Classification: Interventional fluoroscopic x-ray system - Product Code OWB
• 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.
• Code Information: Serial Numbers: 164033 164071 164034 164095 164057 164054 164055 164080 164072 164088 164048 164094 164068 164019 164013 164073 164025 164026 164027 164060 164083 164113 164021 164066 164075 164074 164084 164086 164098 164028 164053 164063 164064 164105 164024 164049 164018 164022 164061 164115 164100 164097 164011
• Recalling Firm/ Manufacturer: Siemens Medical Solutions USA, Inc; 40 Liberty Blvd; Malvern PA 19355-1418
• For Additional Information Contact: Meredith Adams; 610-219-4834
• Manufacturer Reason for Recall: Potential hardware issue which may cause thermal effects and possible damage to system parts.
• FDA Determined Cause: Nonconforming Material/Component
• Action: On June 22, 2018, Siemens Healthineers issued URGENT MEDICAL DEVICE CORRECTION notices to customers via courier service. In the event the problem occurs, the system can be operated normally, however, in the case of a leakage current, X-ray will not be possible. This may result in a situation where it is necessary to cancel or restart clinical treatment or to continue treatment on an alternative system. Please follow the standard emergency procedures you have in place in the event of system failures. It is recommended to consider reinforcing these emergency procedures until the update has been completed. Siemens will correct the error by updating all affected generators with a RCD (Residual Current Device) to detect leakage currents via Update Instruction AX060/16/S. Additionally, Siemens recommends installing a RCD (Residual Current Device) in the electrical system of the hospital as an appropriate backup system and general electrical protection. You may continue to use the Artis Q and Artis Pheno systems while awaiting implementation of the corrective action. Siemens Healthineers will contact customers to arrange a date to perform this corrective action. Please feel free to contact the service organization for an earlier appointment at 1-800-888-7436.
• Quantity in Commerce: 605 units in total
• Distribution: US Nationwide Distribution
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = OWB and Original Applicant = SIEMENS MEDICAL SOLUTION USA, INC.