FDA recall Z-0808-2018

Siemens Medical Solutions USA, Inc · Class II · device

Product

Syngo.via systems with SW VB20A

Reason for recall

A software update was released on August 22, 2017. Performing this software installation and upgrading syngo.via system to the software version VB20A_HF02 will resolve various bugs and inconsistent diagnosis with the old system.

Distribution

Nationwide Distribution.

Key facts

Status: Terminated
Initiation date: 2017-08-31
Report date: 2018-03-07
Termination date: 2018-10-01
Voluntary/Mandated: Voluntary: Firm initiated
Location: Malvern, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0808-2018