FDA-Device2026-09-02Class IIPROCESSING DEFECT

GE Portrait Compute and Core Services V1.2 software recalled for patient monitoring loss risk

What this means

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

  • Do not install Portrait Compute and Core Services V1.2 on affected devices
  • Contact GE Medical Systems Information Technologies Inc for guidance on your specific system
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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
All ages
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
4 units
Manufactured in
3114 N Grandview Blvd, N/A, Waukesha, WI, United States
Products
PORTRAIT COMPUTE AND CORE SERVICES V1.2, Ref# 5700592

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3037-2026

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