ClearanceBrief
Recall Z-2474-2018 ยท JAK System, X-Ray, Tomography, Computed

Siemens Medical Solutions USA, Inc

SOMATOM Perspective (Model 10495568)

DateMar 30, 2018 (initiated Feb 1, 2018)
StatusTerminated
ReasonA potential risk of unnecessary radiation exposure due to a software issue
Root causeSoftware design
ActionCustomers were sent notification letter via USPS with Certified Mail Receipts and Electronic Receipts.
DistributionNationwide
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K113287SOMATOM PERSPECTIVE
Siemens Medical Solutions USA, Inc., May 23, 2012