Buy me a coffee
Home › FDA recalls › FRU
CLASS II · ModerateFDA

GE Medical Systems Information Technologies Inc recalls FRU

📅 Jul 20, 2026 · 📍 MI, NY
Recalling company
GE Medical Systems Information Technologies Inc
Product
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.
Classification
Class II – may cause temporary or medically reversible health consequences
Recall date
Jul 20, 2026
Reported
Sep 2, 2026
Distribution
US: MI, NY and Australia, Czech Republic, Finland, Germany, Italy, Netherlands, Qatar, Saudi Arabia, Switzerland, United Arab Emirates, United Kingdom.
Status
Ongoing
Quantity
0
Lot / codes
UDI-DI (GTIN) 00195278679307
Company location
Waukesha, WI
Recall type
Voluntary: Firm initiated
Recall number
Z-3039-2026
Agency
U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-3039-2026 in the FDA Enforcement Report. Also see FDA recall press releases.

If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.