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

Magnetom Skyra magnetic resonance diagnostic devices recalled

Siemens Medical Solutions USA is recalling Magnetom Skyra 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 # 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

Quantity recalled44

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-2343-2019
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 Skyra magnetic resonance diagnostic devices Model # 10432915

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 Skyra magnetic resonance diagnostic devices recalled?

Yes. Siemens Medical Solutions USA recalled Magnetom Skyra magnetic resonance diagnostic devices on 9 Jul 2019. The recall is Class II and its status is Terminated. Recall number Z-2343-2019.

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 # 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

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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