FRU recall (GE Medical Systems Information Technologies Inc)
Medical deviceClass IIOngoing
Summary: GE Medical Systems Information Technologies Inc is recalling FRU (Field replaceable unit), PORTRAIT CORE SERVICES SW RELOAD V1.1, Ref# 5700225. Reason: 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.
What is being recalled
FRU (Field replaceable unit), PORTRAIT CORE SERVICES SW RELOAD V1.1, Ref# 5700225
Why
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.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
US: MI, NY and Australia, Czech Republic, Finland, Germany, Italy, Netherlands, Qatar, Saudi Arabia, Switzerland, United Arab Emirates, United Kingdom. (states named: Michigan, New York)
How to tell if yours is affected
UDI-DI (GTIN) 00195278679307
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-3039-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | July 20, 2026 |
| Reported | September 2, 2026 |
| Company | GE Medical Systems Information Technologies Inc |
| Company location | Waukesha, WI, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 0 |
More recalls from GE Medical Systems Information Technologies Inc · all medical device recalls · recalls from July 2026