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FDA (Device enforcement)Recalled 2026-07-20class ii

GE Medical Systems Information Technologies Inc: FRU (Field replaceable unit), PORTRAIT CORE SERVICES SW RELOAD V1.1, Ref# 5700225

Is my product affected?

FRU (Field replaceable unit), PORTRAIT CORE SERVICES SW RELOAD V1.1, Ref# 5700225

  • UPC 00195278679307

Check against the official notice below — it lists the full affected range.

What happened

GE Medical Systems Information Technologies Inc. is recalling the PORTRAIT CORE SERVICES SW RELOAD V1.1 (Reference Number 5700225) due to a software issue that may cause loss of patient monitoring at the Hub and Central Viewer. Additionally, the software update may reset all alarm settings to factory defaults, preventing alarms from following the patient or care area-specific configurations that were previously established.

The affected product was distributed in the United States (Michigan and New York) and internationally in Australia, Czech Republic, Finland, Germany, Italy, Netherlands, Qatar, Saudi Arabia, Switzerland, United Arab Emirates, and the United Kingdom. The source document does not specify a remedy for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

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.

Details from the source

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. Quantity: 0 Lot/code info: UDI-DI (GTIN) 00195278679307

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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