Recall Z-2245-2016 ยท LLZ System, Image Processing, Radiological
Siemens Medical Solutions USA, Inc
Syngo.via, picture archiving and communications system software controlled. Intended to be used for viewing, manipulation, communication, and storage of medical images.
| Date | Jun 23, 2016 |
| Status | Terminated |
| Reason | Incorrect values for the volume calculation. Software update VB30B via Update Instructions SY018/16/P to resolve software errors. |
| Root cause | Software design |
| Action | Siemens released and mailed to customers a notice with software update VB30B instructions via update instruction SY018/16/P for customers to follow until the update can be made. The letter also described the software issues involved; and asked customers to include the letter in the operator's manual until the update is performed. Customers are to ensure that all necessary personnel are aware of the situation. |
| Quantity | 50 units |
| Distribution | Nationwide Distribution -- AR, CA, CO, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, ND, NE, NJ, NM, NV, NY, OH, OK, PA, SC, TX, and UT. |
| FDA record | Open on fda.gov |