CLASS II Device recall · Reported 28 Aug 2019 · FDA Enforcement Report
Magnetom Spectra magnetic resonance diagnostic devices recalled
Siemens Medical Solutions USA is recalling Magnetom Spectra 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
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-2344-2019
- 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 Spectra magnetic resonance diagnostic devices Model # 10837643
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
AlabamaArkansasArizonaCaliforniaColoradoConnecticutDistrict of ColumbiaFloridaGeorgiaIowaIllinoisKansasKentuckyLouisianaMassachusettsMarylandMichiganMinnesotaMissouriMontana
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 # 72030 72023
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| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Magnetom Prisma magnetic resonance diagnostic devices recalled | Siemens Medical Solutions USA | Other | 34 states | |
| CLASS II | Magnetom Skyra magnetic resonance diagnostic devices recalled | Siemens Medical Solutions USA | Other | 34 states | |
| CLASS II | Magnetom Aera magnetic resonance diagnostic devices recalled | Siemens Medical Solutions USA | Other | 34 states |
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