—#175138

Product

MAGNETOM Skyra magnetic resonance diagnostic devices Model # 10432915

FDA product code: LNH — System, Nuclear Magnetic Resonance Imaging
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K111242
Affected 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

Why it was recalled

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

Root cause (FDA determination)

Device Design

Action the firm took

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

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 40 Liberty Blvd, Malvern, Pennsylvania 19355-1418

Distribution

Distribution pattern: 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

Timeline

Recall initiated: 2019-07-09
Terminated: 2020-04-23
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #175138. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.