Z-1459-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- May 9, 2018
- Initiation Date
- February 15, 2018
- Termination Date
- April 8, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1301
Product Description
SOMATOM Emotion Duo (2003) Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
Reason for Recall
To inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm for head scans based on p.a. (posterior-anterior) or a.p. (anterior-posterior) topograms. Depending on the geometrical shape of the skull bone, it may happen in rare cases that the calculated dose distribution is not appropriate and could lead to unnecessary radiation exposure
Distribution Pattern
USA (nationally) Distribution.
Code Information
3813933