Class 2 Device Recall Siemens

• Date Initiated by Firm: March 04, 2021
• Date Posted: April 19, 2021
• Recall Status: Open, Classified
• Recall Number: Z-1434-2021
• Recall Event ID: 87515
• 510(K)Number: K150493
• Product Classification: Computer, diagnostic, programmable - Product Code DQK
• Product: Sensis/ Sensis Vibe Hemo systems with VD12A software as follows:; ; Dedicated SIS Server- 6648153; Sensis Post-Processing Workstation- 6648161; Sensis- 10764561; VM Virtual Server- 10765502; Sensis High-End Servers- 10910620; Sensis Vibe Hemo- 11007641; Sensis Vibe Combo- 11007642; ; Sensis Vibe is a recording and procedure data management system for interventional cardiology, interventional radiology, surgical procedures performed in a hybrid OR and electrophysiology
• Code Information: Serial Numbers: As of 8/24/22 (Updated) 10661 11657 14000 14012 14123 14312 14603 14804 14900 14902 15010 15130 15135 15136 15819 15829 15902 15903 15904 15908 15913 15915 15916 15917 15920 15923 15924 15925 15926 15927 15928 18900 18901 100208 100209 100216 100306 100309 102138 102145 102147 102221 102326 103014 103019 103022 103039 103040 103042 103047 103048 103079 103080 103082 103086 103088 103089 103090 103108 103111 103114 103115 103116 103117 103119 103123 103124 103130 103131 103139 103144 103145 103148 103152 103160 103161 103166 103167 103168 103170 103171 103172 103173 103177 103178 103182 103184 103186 103189 103193 103194 103196 103198 103199 103200 103208 103216 123004 123021
• Recalling Firm/ Manufacturer: Siemens Medical Solutions USA, Inc; 40 Liberty Blvd; Malvern PA 19355
• For Additional Information Contact: SAME; 610-219-4834
• Manufacturer Reason for Recall: Due to the configuration of certain Windows Service Permissions within the operating systems of the Sensis/ Sensis Vibe computer, there is a risk for exposure of sensitive information, manipulation of data, or Denial of Service attacks and could result in incorrect diagnostic or therapeutic decisions
• FDA Determined Cause: Software design
• Action: Siemens Healthineers issued Customer Safety Advisory Notice dated 3/4/21 to affected customers via AX074/20/S. Letter states reason for recall, health risk and action to take: Siemens will restrict the Windows Service Permissions to the required level only and the IT security vulnerability of your system will be reduced via Update Instruction AX073/20/S. Our service organization will contact you shortly to arrange a date to perform this corrective action. Please feel free to contact our service organization for an earlier appointment at 1-800-888-7436. Please review, understand, and confirm acknowledgement of the information and instructions outlined in this Urgent Safety Advisory Notice. By signing this document, you are acknowledging that you have read and understand the content therein. .
• Quantity in Commerce: 99 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 = DQK and Original Applicant = Siemens Medical Solutions, Inc.