CLASS II Device recall · Reported 28 Aug 2019 · FDA Enforcement Report

Magnetom Aera magnetic resonance diagnostic devices recalled

Siemens Medical Solutions USA is recalling Magnetom Aera magnetic resonance diagnostic devices, distributed in 34 states. The recall was initiated on 9 Jul 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial # 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

Quantity recalled143

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2342-2019
FDA event ID: 83415
Recalling firm: Siemens Medical Solutions USA, Malvern, PA
Classification: Class II
Status: Terminated
Recall initiated: 9 Jul 2019
FDA classified: 22 Aug 2019
Reported: 28 Aug 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Test Kits & Diagnostics

Timeline

9 Jul 2019	Recall initiated by company
22 Aug 2019	Classified by FDA	+44 days
28 Aug 2019	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

MAGNETOM Aera magnetic resonance diagnostic devices Model # 10432914

Where it was distributed

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

Alabama Arkansas Arizona California Colorado Connecticut District of Columbia Florida Georgia Iowa Illinois Kansas Kentucky Louisiana Massachusetts Maryland Michigan Minnesota Missouri Montana

Questions about this recall

Is Magnetom Aera magnetic resonance diagnostic devices recalled?

Yes. Siemens Medical Solutions USA recalled Magnetom Aera magnetic resonance diagnostic devices on 9 Jul 2019. The recall is Class II and its status is Terminated. Recall number Z-2342-2019.

Why was it recalled?

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

Which lots are affected?

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

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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