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

Magnetom Prisma magnetic resonance diagnostic devices recalled

Siemens Medical Solutions USA is recalling Magnetom Prisma 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 # 66109 66111 166049 66047 166037 66102 66027 66053 66094 66028 66069 66092 66046 66082 166097 66044 166082

Quantity recalled17

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-2345-2019
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 Prisma magnetic resonance diagnostic devices Model #10849582

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

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 # 66109 66111 166049 66047 166037 66102 66027 66053 66094 66028 66069 66092 66046 66082 166097 66044 166082

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

Other products in this recall event

3 other products · FDA event 83415

This product is part of a recall event; the main page for the event is Magnetom Spectra magnetic resonance diagnostic devices recalled.

Reported	Class	Recall	Company	Reason	Where
28 Aug 2019	CLASS II	Magnetom Spectra magnetic resonance diagnostic devices recalled	Siemens Medical Solutions USA	Other	34 states
28 Aug 2019	CLASS II	Magnetom Skyra magnetic resonance diagnostic devices recalled	Siemens Medical Solutions USA	Other	34 states
28 Aug 2019	CLASS II	Magnetom Aera magnetic resonance diagnostic devices recalled	Siemens Medical Solutions USA	Other	34 states

Reported	Class	Recall	Company	Reason	Where
8 Jul 2026Device	CLASS II	Artis icono ceiling recalled by Siemens Medical Solutions USA	Siemens Medical Solutions USA	Other	Nationwide
8 Jul 2026Device	CLASS II	Artis icono biplane recalled by Siemens Medical Solutions USA	Siemens Medical Solutions USA	Other	Nationwide
8 Jul 2026Device	CLASS II	Artis icono floor recalled by Siemens Medical Solutions USA	Siemens Medical Solutions USA	Other	Nationwide
8 Jul 2026Device	CLASS II	Artis icono ceiling recalled by Siemens Medical Solutions USA	Siemens Medical Solutions USA	Other	Nationwide
10 Jun 2026Device	CLASS II	Artis pheno recalled by Siemens Medical Solutions USA	Siemens Medical Solutions USA	Other	PA

Other Test Kits & Diagnostics recalls

All 2,656

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Device	CLASS II	STA Staclot Protein recalled by Diagnostica Stago	Diagnostica Stago	Potency & Assay	Nationwide
26 Aug 2026Device	CLASS II	DxC 500i Clinical Analyzer Modules using recalled by Beckman Coulter	Beckman Coulter	Packaging Defects	Nationwide
26 Aug 2026Device	CLASS II	DxC 500 AU Clinical Analyzer Modules using recalled by Beckman Coulter	Beckman Coulter	Packaging Defects	Nationwide
26 Aug 2026Device	CLASS II	Syva EMIT 2000 Quinidine Assay recalled	Siemens Healthcare Diagnostics	Potency & Assay	Nationwide
26 Aug 2026Device	CLASS II	Beckman Coulter, Emit 2000 Quinidine Assay recalled	Siemens Healthcare Diagnostics	Potency & Assay	Nationwide