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FDA · Medical devices ·

PORTRAIT CORE SERVICES SOFTWARE V1.0.5, Ref# 5697353 recall

GE Medical Systems Information Technologies Inc recalled PORTRAIT CORE SERVICES SOFTWARE V1.0.5, Ref# 5697353 on September 2, 2026 because of software issue may result in a loss of patient monitoring at the Hub and Central Viewer. It was sold in MI, NY.

Why it was recalled

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's recalled

PORTRAIT CORE SERVICES SOFTWARE V1.0.5, Ref# 5697353

Quantity: 15 units

What to do

Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.

Read the official FDA notice

Details

Company
GE Medical Systems Information Technologies Inc, Waukesha, WI
Date
Severity
Class II
the product could cause temporary or reversible health problems.
Where sold
MI, NY
US: MI, NY and Australia, Czech Republic, Finland, Germany, Italy, Netherlands, Qatar, Saudi Arabia, Switzerland, United Arab Emirates, United Kingdom.
Status
Ongoing
Recall number
Z-3038-2026
Source
U.S. Food and Drug Administration

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