ClearanceBrief
Recall Z-2476-2018 ยท JAK System, X-Ray, Tomography, Computed

Siemens Medical Solutions USA, Inc

SOMATOM Scope ( Model 10967666)

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

K140912SOMATOM SCOPE/SOMATOM SCOPE POWER
Siemens Medical Solutions USA, Inc., Sep 15, 2014