Class 2 Device Recall Cios Spin

• Date Initiated by Firm: April 17, 2020
• Date Posted: May 04, 2020
• Recall Status: Terminated on August 25, 2020
• Recall Number: Z-2128-2020
• Recall Event ID: 85572
• 510(K)Number: K181550
• Product Classification: Interventional fluoroscopic x-ray system - Product Code OWB
• Product: Cios Spin Image-Intensified Fluoroscopic X-Ray System, Model Numbers VA30-10308194
• Code Information: Serial Numbers: 50135 50131 50171 50129 50048 50184 50180 50136 50185 50153 50155 50130 50127 50134 50166 50192 50161 50128 50132 50160
• Recalling Firm/ Manufacturer: Siemens Medical Solutions USA, Inc; 40 Liberty Blvd; Malvern PA 19355
• For Additional Information Contact: Meredith Adams; 610-219-4834
• Manufacturer Reason for Recall: The unplugging of the main cable on the monitor trolley from the X10 connector can cause an unsafe electrical voltage (up to 67,6 V DC) at the X10 connector. This can result in an electrical shock if the user or other persons touch the contact pins of the X10 connector.
• FDA Determined Cause: Device Design
• Action: URGENT: MEDICAL DEVICE CORRECTION notification letters dated 4/17/20 were sent to customers. What is the impact to the operation of the system and what are the possible risks? There is no impact to the operation of the system, however, unplugging the main cable can cause an unsafe electrical voltage (up to 67,6 V DC) at the X10 connector which can result in an electrical shock if the user or other persons touch the contact pins of the X10 connector. How was the subject identified and what is the root cause? The issue was identified by the manufacturer during system assembly when the plug of the main cable was unplugged. The root cause is a design flaw in a generator component of the generator Polydoros M25 revision 04. What actions do we recommend urgently to mitigate possible risks? We strongly recommend that you do not unplug the main cable until the generator is repaired by a service engineer. How will the corrective action be implemented and what is the efficiency of the corrective actions? Siemens will correct the hardware error via Update Instruction AX028/20/S in which a Siemens Service Engineer will repair the generator at your site. 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. Following the correction, the cause is eliminated, and any recurrence of this potential fault is prevented. Acknowledge Receipt of this Safety Advisory Notice 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: 20
• Distribution: US Nationwide Distribution to states of: AR, AZ, CA, FL, IL, IN, MA, MD, MI, MN, NC, NE, NH, NJ, NY, OH, OK, SC, TN, TX, UT, VA, WA, and Puerto Rico.
• 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 Solutions USA, Inc.