FRU (Field replaceable unit) recall
GE Medical Systems Information Technologies Inc recalled FRU (Field replaceable unit) 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
FRU (Field replaceable unit), PORTRAIT CORE SERVICES SW RELOAD V1.1, Ref# 5700225
Quantity: 0
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 noticeDetails
- 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-3039-2026
- Source
- U.S. Food and Drug Administration
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