FDA Recall Terminated

MAGNETOM Aera magnetic resonance diagnostic devices Model # 10432914

Recall: Z-2342-2019 · Initiated July 9, 2019

Recall

Recall Number
Z-2342-2019
Event Number
83415
Firm
Siemens Medical Solutions USA, Inc
FEI Number
2240869
Product Code
LNH
Status
Terminated
Root Cause
Device Design
Initiated
July 9, 2019
Terminated
April 23, 2020
Address
40 Liberty Blvd, Malvern, PA, 19355-1418

Description

MAGNETOM Aera magnetic resonance diagnostic devices Model # 10432914

Reason

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

Action

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: [email protected]

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

Quantity

143