FDA recall Z-1303-2018

Product

Syngo.via. Medical Device Software. Picture archiving and communications system.

Reason for recall

A software functionality in the report sections Findings Information and Summary of Measured Findings is not performing properly. The system will use the original values instead of displaying and saving corrected/modified values. Outdated information could be sent to the referring physician when creating the formal report in the reporting system.

Distribution

Device is software only. No products are distributed to wholesale dealers, distributers or retailers

Key facts

Status

Terminated

Initiation date

2018-01-08

Report date

2018-04-11

Termination date

2020-04-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

Malvern, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1303-2018