FDA-Device2018-05-09Class II
SOMATOM Spirit Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
Siemens Medical Solutions USA, Inc
Hazard
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
Sold states
USA (nationally) Distribution.
Affected count
1301
Manufactured in
40 Liberty Blvd, N/A, Malvern, PA, United States
Products
SOMATOM Spirit Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1451-2018Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief