FDA Enforcement Class II Terminated

MAGNETOM Aera magnetic resonance diagnostic devices Model # 10432914

Recall: Z-2342-2019 · Reported August 28, 2019

Enforcement

Recall Number
Z-2342-2019
Event ID
83415
Classification
Class II
Status
Terminated
Product Type
Devices
Firm
Siemens Medical Solutions USA, Inc
Voluntary / Mandated
Voluntary: Firm initiated
Initial Notification
Letter
Report Date
August 28, 2019
Initiation Date
July 9, 2019
Classification Date
August 22, 2019
Termination Date
April 23, 2020
Address
40 Liberty Blvd, N/A, Malvern, PA, 19355-1418, United States

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.

Code Info

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

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