MAGNETOM Skyra magnetic resonance diagnostic devices Model # 10432915

This recall has been terminated (originally issued July 9, 2019).

Company: Siemens Medical Solutions Usa, Inc
Recall Initiated: July 9, 2019
Terminated: April 23, 2020
Recall Number: Z-2343-2019
Quantity: 44
Firm Location: Malvern, PA
Official Source: View on FDA website ↗

Reason for Recall

Potential of an open port in the quench venting system when using the optional horizontal outlet on the quench line assembly.

Distribution

AL AR AZ CA CO CT DC DE FL GA GU IA ID IL IN KS KY LA MA MD ME MI MN MO MT NC NE NH NJ NY OH OK OR PA SC TN TX VA WA WI WV WY

Lot / Code Info

Serial # 46066 45732 46182 45735 45805 46171 45693 45886 45988 45881 46144 46044 46176 46179 46032 46238 145161 46127 45774 45968 46196 46175 45681 46007 46021 46105 46142 45928 45815 46150 145302 45878 46239 46026 145403 45667 145536 45970 45839 45982 46145 46298 45777 46294

Root Cause

Device Design

Action Taken

1. review the System Owner Manual chapter 1.3.3 Quench emergency plan and the section regarding defective vent line. 2. follow the standard emergency procedures you have in place in the event of system failures. 3.A Siemens Service Technician will conduct an inspection to verify that your system has a vertical outlet. If a vertical outlet is present, no further action is required. In the event your system is equipped with a horizontal outlet, the Siemens Service Technician will ensure that the port for the drop-off plate is adequately blanked off or sealed. 4.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. 5. Please review, understand, and confirm acknowledgement of the information and instructions outlined in this Customer Safety Advisory Notice. By signing this document you are acknowledging that you have read and understand the content therein. If you have any question, please contact Meredith Adams, Telephone 610-448-6461 and E-Mail: Meredith.adams@siemens-healthineers.com