FDA recall Z-3036-2026

GE Medical Systems Information Technologies Inc · Class II · device

Product

PORTRAIT CORE SERVICES SOFTWARE V1.1, Ref# 5700209

Reason for recall

Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. In addition, all alarm settings could be reset to factory defaults following the update and will not follow the alarm settings previously configured for each patient or care area.

Distribution

US: MI, NY and Australia, Czech Republic, Finland, Germany, Italy, Netherlands, Qatar, Saudi Arabia, Switzerland, United Arab Emirates, United Kingdom.

Key facts

Status: Ongoing
Initiation date: 2026-07-20
Report date: 2026-09-02
Voluntary/Mandated: Voluntary: Firm initiated
Location: Waukesha, WI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3036-2026