FDA-Device2026-09-02Class IIPROCESSING DEFECT

GE Portrait Core Services Software V1.1 recalled for patient monitoring loss and alarm reset risk

What this means

GE Medical Systems Portrait Core Services Software V1.1 contains a software issue that may cause loss of patient monitoring at the Hub and Central Viewer. The update may also reset all alarm settings to factory defaults, overriding previously configured alarm settings for individual patients or care areas.

  • Contact GE Medical Systems Information Technologies Inc for guidance on the software update
  • Do not install the update until you receive corrective instructions
  • Verify patient monitoring and alarm settings after any software changes
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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
23 units
Manufactured in
3114 N Grandview Blvd, N/A, Waukesha, WI, United States
Products
PORTRAIT CORE SERVICES SOFTWARE V1.1, Ref# 5700209

Official notice

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

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