FDA recall Z-2944-2020

Product

Merge PACS

Reason for recall

Measurements done on the Merge PACS generated MPR s may have incorrect measurements.

Distribution

Domestic Distribution: IL, MO, NY, ND, MI, TX, FL, OH, UT, NE, MS, MN, DE, AR, CA, WI, MD, NC, NH, GA, VA, SC, PE, CT, NM, IN. International Distribution: CA, BE, UK.

Key facts

Status

Terminated

Initiation date

2020-08-06

Report date

2020-09-16

Termination date

2022-11-30

Voluntary/Mandated

Voluntary: Firm initiated

Location

Hartland, WI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2944-2020