Recall Ledger

PORTRAIT CORE SERVICES SOFTWARE V1.0.5 recall (GE Medical Systems Information Technologies Inc)

Medical deviceClass IIOngoing

Summary: GE Medical Systems Information Technologies Inc is recalling PORTRAIT CORE SERVICES SOFTWARE V1.0.5, Ref# 5697353. 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

PORTRAIT CORE SERVICES SOFTWARE V1.0.5, Ref# 5697353

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

GTIN 00195278364838, Serial Numbers: SUC23080050TA, SUD22470001TA, SUD22420001TA, SUD22470010TA, SUD23390001TA, SUD23390003TA, SUD23390004TA, SUD23390009TA, SUD23390010TA, SUD22470009TA, SUD22470003TA, SUD22470004TA, SUD22470005TA, SUD23390005TA, SUD22280002TA.

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 numberZ-3038-2026
CategoryMedical device
AgencyU.S. Food and Drug Administration (FDA)
SeverityClass II
StatusOngoing
Recall startedJuly 20, 2026
ReportedSeptember 2, 2026
CompanyGE Medical Systems Information Technologies Inc
Company locationWaukesha, WI, United States
Initiated byVoluntary: Firm initiated
Quantity15 units

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