FDA recall Z-1446-2018

Siemens Medical Solutions USA, Inc · Class II · device

Product

SOMATOM Emotion 16 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

USA (nationally) Distribution.

Key facts

Status
Terminated
Initiation date
2018-02-15
Report date
2018-05-09
Termination date
2020-04-08
Voluntary/Mandated
Voluntary: Firm initiated
Location
Malvern, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1446-2018