FDA Enforcement
Class II
Terminated
Cios Alpha, mobile X-ray system
Recall: Z-1278-2016
·
Reported April 6, 2016
Enforcement
- Recall Number
- Z-1278-2016
- Event ID
- 73605
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Siemens Medical Solutions USA, Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- April 6, 2016
- Initiation Date
- February 19, 2016
- Classification Date
- March 31, 2016
- Termination Date
- March 20, 2017
- Address
- 40 Liberty Blvd, N/A, Malvern, PA, 19355-1418, United States
Description
Cios Alpha, mobile X-ray system
Reason
Software issues on Cios Alpha mobile C-Arm system
Code Info
Model # 10308191
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
Quantity
89 systems