FDAFDA recall Z-3039-2026 · Sep 2, 2026
GE Medical Systems Information Technologies Inc: FRU (Field replaceable unit) recall
Recall found
Product
FRU (Field replaceable unit), PORTRAIT CORE SERVICES SW RELOAD V1.1, Ref# 5700225
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.
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- UDI-DI (GTIN) 00195278679307
- Quantity
- 0
- Distribution
- US: MI, NY and Australia, Czech Republic, Finland, Germany, Italy, Netherlands, Qatar, Saudi Arabia, Switzerland, United Arab Emirates, United Kingdom.
- Recalling firm
- GE Medical Systems Information Technologies Inc, Waukesha, WI
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-07-20
Source: openFDA enforcement record Z-3039-2026 · search recall number Z-3039-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.