FDA recall Z-1778-2018

Siemens Medical Solutions USA, Inc · Class II · device

Product

Syngo.Via VB20A model 1049610

Reason for recall

Functionality in the report sections "Findings Information" and "Summary of Measured Findings" not functioning properly. The corrected values modified in the report are neither saved, nor printed, nor sent to the information system. The system will still use original values.

Distribution

Nationwide

Key facts

Status: Terminated
Initiation date: 2018-03-27
Report date: 2018-05-16
Termination date: 2020-06-15
Voluntary/Mandated: Voluntary: Firm initiated
Location: Malvern, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1778-2018