FDA-Device2026-09-02Class IIPROCESSING DEFECT

GE PORTRAIT Core Services software update may disable patient monitoring and reset alarms

What this means

A software update to GE's PORTRAIT Core Services monitoring system can cause patient monitoring to stop working at the Hub and Central Viewer. The update may also reset all alarm settings back to factory defaults, overriding the custom alarm configurations that were previously set for individual patients or care areas.

  • Contact GE Medical Systems Information Technologies Inc for guidance before applying this software update
  • Review your alarm settings after any update to confirm they match your facility's requirements
  • Verify patient monitoring is functioning properly at both the Hub and Central Viewer after the update
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The agency's original wording
Hazard

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.

Intended for
Adults
Illnesses reported
None reported
Sold states
US: MI, NY and Australia, Czech Republic, Finland, Germany, Italy, Netherlands, Qatar, Saudi Arabia, Switzerland, United Arab Emirates, United Kingdom.
Affected count
0
Manufactured in
3114 N Grandview Blvd, N/A, Waukesha, WI, United States
Products
FRU (Field replaceable unit), PORTRAIT CORE SERVICES SW RELOAD V1.1, Ref# 5700225

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3039-2026

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