FDA recall Z-2591-2017

Product

Merge PACS software. Merge PACS (Picture Archiving Communication System) is designed and marketed for soft copy reading, communication, and storage of studies produced by digital modalities, including digital mammography

Reason for recall

When cut lines are shown on an image, the lines may go from being vertical and then shift to horizontal causing confusion to the physician. This may cause a misdiagnosis.

Distribution

Nationwide Distribution

Key facts

Status

Terminated

Initiation date

2017-05-08

Report date

2017-06-21

Termination date

2019-08-08

Voluntary/Mandated

Voluntary: Firm initiated

Location

Hartland, WI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2591-2017