Class 2 Device Recall MAGNETOM Aera

• Date Initiated by Firm: July 09, 2019
• Create Date: August 22, 2019
• Recall Status: Terminated on April 23, 2020
• Recall Number: Z-2342-2019
• Recall Event ID: 83415
• 510(K)Number: K111242
• Product Classification: System, nuclear magnetic resonance imaging - Product Code LNH
• Product: MAGNETOM Aera magnetic resonance diagnostic devices Model # 10432914
• Code Information: Serial # 41878 52409 142129 141526 42163 152267 141686 42436 42160 142132 41953 141226 141862 141521 42225 52171 41980 41051 152232 42247 141462 52299 52338 42416 141199 141557 142109 141054 152249 42020 41794 142147 152217 141951 42458 141638 42087 142010 42326 142009 142124 141676 42290 52229 42298 142130 141561 141973 42530 141141 41951 42236 152215 42267 42364 141305 42372 142122 42083 142142 42217 52195 152175 41945 141712 42256 42310 41780 42422 141963 42534 52350 52249 42412 42413 52397 41862 141786 42420 52221 52304 42306 141513 142024 141016 42495 142120 41906 52267 141589 42249 42158 41897 52321 42303 141056 42353 42330 41778 141275 141109 142107 42381 42339 41777 152234 52190 141201 42566 141677 41782 42254 42214 52192 141314 141585 42248 42295 42517 141072 42417 141439 141975 142104 41941 41813 141260 42533 141386 52157 141154 141135 142128 141121 142077 141242 142074 141253 141043 141221 42635 42507 141025
• Recalling Firm/ Manufacturer: Siemens Medical Solutions USA, Inc; 40 Liberty Blvd; Malvern PA 19355-1418
• For Additional Information Contact: Meredith Adams; 610-219-4834
• Manufacturer Reason for Recall: Potential of an open port in the quench venting system when using the optional horizontal outlet on the quench line assembly.
• FDA Determined Cause: Device Design
• 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: Meredith.adams@siemens-healthineers.com
• Quantity in Commerce: 143
• 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
• 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 = LNH