Class 2 Device Recall Aris zee/zeego and Artix Q/Q.zen

• Date Initiated by Firm: March 21, 2024
• Date Posted: April 18, 2024
• Recall Status: Open, Classified
• Recall Number: Z-1598-2024
• Recall Event ID: 94299
• 510(K)Number: K181407
• Product Classification: Interventional fluoroscopic x-ray system - Product Code OWB
• Product: Siemens Artis Models: Interventional Fluoroscopic X-Ray Systems-Models: Artis zee floor- 10094135 Artis zee ceiling- 10094137 Artis zee multi-purpose- 10094139 Artis zee biplane- 10094141 Artis zeego- 10280959 Artis Q floor- 10848280 Artis Q ceiling- 10848281 Artis Q biplane- 10848282 Artis Q zeego- 10848283 Artis Q.zen floor- 10848353 Artis Q.zen ceiling- 10848354 Artis Q.zen biplane- 10848355 Artis zee floor MN- 10094142 Artis zee biplane MN- 10094143
• Code Information: Model/UDI-DI: Artis zee floor- 4056869010045 Artis zee ceiling- 4056869010052 Artis zee multi-purpose- 4056869010076 Artis zee biplane- 4056869010069 Artis zee floor MN- 4056869010090 Artis zee biplane MN- 4056869010106 Artis zeego- 4056869010083 Artis Q floor- 4056869009971 Artis Q ceiling- 4056869009988 Artis Q biplane- 4056869009995 Artis Q zeego- 4056869010007 Artis Q.zen floor- 4056869010014 Artis Q.zen ceiling- 4056869010021 Artis Q.zen biplane- 4056869010038
• Recalling Firm/ Manufacturer: Siemens Medical Solutions USA, Inc; 40 Liberty Blvd; Malvern PA 19355-1418
• For Additional Information Contact: SAME; 610-219-4834
• Manufacturer Reason for Recall: Coolant level in the cooling circuit drops below a certain level, this may result in a situation in which the X-ray tube is no longer sufficiently cooled and the system will display the message TUBE HOT, have a break . the system cannot be operated normally, may result in a situation where it is necessary to cancel clinical treatment or to continue treatment on an alternative system
• FDA Determined Cause: Device Design
• Action: Siemens issued Urgent Medical Device Correction letter (AX034/23/S) to US accounts Director of Diagnostic Imaging and/ or Radiology Laboratory to users of Artis zee, Artis zeego, Artis Q, Artis Q.zen and Artis Q zeego systems on 3/21/24. Letter states reason for recall, health risk and action to take: As the released corrective action to install a water level sensor is not applicable to your site due to the local building setup, Siemens Healthineers is advising users of Artis systems to check the cooling units and refill with water according to the provided Instruction for Use of the Artis system. As described in the Operator Manual, we recommend that the system operator checks the water level of the cooling circuit at least every three months and refills water In addition, a label will be affixed on the start-up console of the Artis system in the control room to remind users to check the cooling water levels. As a courtesy, Siemens service organization will check the water level once outside the regular maintenance interval. Prospectively, the check of the cooling level is part of each maintenance. Please ensure that all users of the affected products within your organization and others who may need to be informed will receive the relevant safety information provided within this notice and will comply with the recommendations therein. Acknowledge Receipt of this Safety Advisory Notice
• Quantity in Commerce: 583 units
• 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = OWB