ClearanceBrief
Recall Z-1953-2019 ยท OWB Interventional Fluoroscopic X-Ray System

Siemens Medical Solutions USA, Inc

Cios Alpha VA20/ VA30 mobile X-Ray systems

DateJun 20, 2019
StatusTerminated
ReasonDAP chamber may be missing an insulating foil
Root causeNonconforming Material/Component
Action1. Siemens will inspect the DAP chamber on your unit, and if necessary, replace it with insulated DAP chamber. 2. Siemens service organization will contact you shortly to arrange a date to perform this corrective action. 3. Please feel free to contact our service organization for an earlier appointment at 1-800-888-7436.
Quantity1
DistributionIL, NE
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K132094CIOS ALPHA
Siemens Medi Cal Solutions, Inc., Mar 11, 2014
K181560Cios Alpha
Siemens Medical Systems USA, Inc., Oct 24, 2018