Class IIDeviceOngoing

GE Medical Systems Information Technologies Inc

PORTRAIT CORE SERVICES SOFTWARE V1.0.5, Ref# 5697353

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.

Details

Recall number: Z-3038-2026
Event ID: 99536
Recall initiated: Jul 20, 2026
Classified: Aug 27, 2026
Reported: Sep 2, 2026
Quantity: 15 units
Distribution: US: MI, NY and Australia, Czech Republic, Finland, Germany, Italy, Netherlands, Qatar, Saudi Arabia, Switzerland, United Arab Emirates, United Kingdom.
Initiated by: Voluntary: Firm initiated
Firm notification: Letter
Firm location: Waukesha, WI, United States
Lot / code info: GTIN 00195278364838, Serial Numbers: SUC23080050TA, SUD22470001TA, SUD22420001TA, SUD22470010TA, SUD23390001TA, SUD23390003TA, SUD23390004TA, SUD23390009TA, SUD23390010TA, SUD22470009TA, SUD22470003TA, SUD22470004TA, SUD22470005TA, SUD23390005TA, SUD22280002TA.