FDA-Device2026-09-02Class IIPROCESSING DEFECT

GE Portrait Core Services Software v1.0.5 recalled for patient monitoring loss and alarm reset risk

What this means

A software update to GE's Portrait Core Services Software v1.0.5 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 any custom alarm configurations set up for individual patients or care areas.

  • If your facility uses this software version, contact GE Medical Systems for guidance before applying or after applying this update
  • Verify that patient monitoring is functioning properly at your Hub and Central Viewer after any software update
  • Confirm that alarm settings have been restored to your facility's configured values
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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
15 units
Manufactured in
3114 N Grandview Blvd, N/A, Waukesha, WI, United States
Products
PORTRAIT CORE SERVICES SOFTWARE V1.0.5, Ref# 5697353

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3038-2026

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