FDA recall, , Moderate risk
GE Portrait Core Services Software
Software issue may result in a loss of patient monitoring at the Hub and Central Viewer.
Summary by Recall Canary from the FDA notice
What happened
GE Medical Systems Information Technologies Inc of Waukesha, Wisconsin began a recall on July 20, 2026, for Portrait Core Services Software V1.1, V1.0.5, and Portrait Compute and Core Services V1.2 due to a software issue that may result in a loss of patient monitoring at the Hub and Central Viewer, and could reset all alarm settings to factory defaults following the update.
The recall was added to the FDA's Enforcement Report on August 27, 2026, and classified that same day. The products were distributed in US: MI, NY and Australia, Czech Republic, Finland, Germany, Italy, Netherlands, Qatar, Saudi Arabia, Switzerland, United Arab Emirates, United Kingdom.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
4 products
Affected if its UDI-DI is listed.
A UDI-DI is the device identifier printed with the barcode on the device label.
Portrait Core Services Software V1.1, Ref# 5700209
- UDI-DI
- 00195278679284
Portrait Core Services Software V1.0.5, Ref# 5697353
- UDI-DI
- 00195278364838
FRU (Field replaceable unit), Portrait Core Services SW Reload V1.1, Ref# 5700225
- UDI-DI
- 00195278679307
Portrait Compute and Core Services V1.2, Ref# 5700592
- UDI-DI
- 00198953056752
Recall details
- Company began the recall
- Sold in
US: Michigan, New York and Australia, Czech Republic, Finland, Germany, Italy, Netherlands, Qatar, Saudi Arabia, Switzerland, United Arab Emirates, United Kingdom.
- Company
- GE Medical Systems Information Technologies IncWaukesha, Wisconsin
- Hazard
- Software defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99536
- Recall numbers
- Z-3036-2026 to Z-3039-2026
All recalls from GE Medical Systems Information Technologies Inc
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
