CLASS II Device recall · Reported 6 Apr 2016 · FDA Enforcement Report
Siemens branded Somatom Emotion recalled
Siemens Medical Solutions USA is recalling Siemens branded Somatom Emotion and Somatom Sensation families of CT systems intended to, distributed nationwide in the US. The recall was initiated on 15 Feb 2016 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-1301-2016
- FDA event ID
- 73477
- Recalling firm
- Siemens Medical Solutions USA, Malvern, PA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 15 Feb 2016
- FDA classified
- 31 Mar 2016
- Reported
- 6 Apr 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- N/A
- Reason category
- Device Malfunction
- Device type
- Imaging Equipment
Timeline
| 15 Feb 2016 | Recall initiated by company | |
| 31 Mar 2016 | Classified by FDA | +45 days |
| 6 Apr 2016 | 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
Siemens is initiating this recall due to a potential malfunction and hence potential hazard to patients and personnel when using the SOMATOM Emotion or SOMATOM Sensation systems in conjunction with the use of the cardio licenses "Cardio Pro" and "Cardio Retro".
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Siemens branded SOMATOM Emotion and SOMATOM Sensation families of CT systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles.
Where it was distributed
US (nationwide) including Guam and the states of AL, AR, AZ, CA, CO, FL, GA, HI, IA, ID, IL, KY, MA, MD, ME, MI, MN, MO, NC, NJ, NM, NY, OH, PA, SC, TN, TX, VA, and WA.
Nationwide AlabamaArkansasArizonaCaliforniaColoradoFloridaGeorgiaHawaiiIowaIdahoIllinoisKentuckyMassachusettsMarylandMaineMichiganMinnesotaMissouriNorth CarolinaNew Jersey
Questions about this recall
Is Siemens branded Somatom Emotion and Somatom Sensation families of CT systems intended to recalled?
Yes. Siemens Medical Solutions USA recalled Siemens branded Somatom Emotion and Somatom Sensation families of CT systems intended to on 15 Feb 2016. The recall is Class II and its status is Terminated. Recall number Z-1301-2016.
Why was it recalled?
Siemens is initiating this recall due to a potential malfunction and hence potential hazard to patients and personnel when using the SOMATOM Emotion or SOMATOM Sensation systems in conjunction with the use of the cardio licenses "Cardio Pro" and "Cardio Retro".
Which lots are affected?
Model Number: SOMATOM Emotion 16 - 7734713
Where was it sold?
US (nationwide) including Guam and the states of AL, AR, AZ, CA, CO, FL, GA, HI, IA, ID, IL, KY, MA, MD, ME, MI, MN, MO, NC, NJ, NM, NY, OH, PA, SC, TN, TX, VA, and WA.
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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