FDA recall Z-2601-2017

Product

Merge OrthoPACS software. The firm name on the label is Merge Healthcare, Hartland, WI.

Reason for recall

Studies that have QC, PDE, or HL7 ADT updates applied may fail to propagate via telmed protocol to the destination server and may fail to import on the destination server.

Distribution

USA (nationwide) Distribution was made to medical facilities. There was no foreign/government/military distribution.

Key facts

Status

Terminated

Initiation date

2017-05-24

Report date

2017-06-28

Termination date

2019-10-15

Voluntary/Mandated

Voluntary: Firm initiated

Location

Hartland, WI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2601-2017