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Recall Observatory FDA recall evidence

Device product

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.

Z-1305-2016

February 15, 2016

Class II

Product summary

Firm
Siemens Medical Solutions USA, Inc
Event
Event 73477
Status
Terminated
Classification
Class II
Quantity
124 units
Official record key
device-enforcement:Z-1305-2016

Official wording

Reason: 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".

Code information: Model Number: SOMATOM Sensation 64/ Cardiac 64 - 8377520

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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".