PlainRecalls
FDA Devices Moderate Class II Terminated

Cios Alpha, mobile X-ray system

Reported: April 6, 2016 Initiated: February 19, 2016 #Z-1278-2016

Product Description

Cios Alpha, mobile X-ray system

Reason for Recall

Software issues on Cios Alpha mobile C-Arm system

Details

Units Affected
89 systems
Distribution
Nationwide Distribution to the states of : AL, AR, CA, CO, CT, DE, FL, GA, IA, IL, KY, MD, MI, MN, MO, NC, NE, NJ, NV, NY, OH, OR, PA, RI, SC, TN, TX, UT, WA and WI
Location
Malvern, PA

Frequently Asked Questions

What product was recalled?
Cios Alpha, mobile X-ray system. Recalled by Siemens Medical Solutions USA, Inc. Units affected: 89 systems.
Why was this product recalled?
Software issues on Cios Alpha mobile C-Arm system
Which agency issued this recall?
This recall was issued by the FDA Devices on April 6, 2016. Severity: Moderate. Recall number: Z-1278-2016.