FDA Medical devices recall ·
PORTRAIT CORE SERVICES SOFTWARE V1.1, Ref# 5700209 recall
- Recall number
- Z-3036-2026
- Date
- (initiated July 20, 2026)
- Company / brand
- GE Medical Systems Information Technologies Inc
3114 N Grandview Blvd, Waukesha, WI, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 23 units
- Hazard tags
- Software
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
PORTRAIT CORE SERVICES SOFTWARE V1.1, Ref# 5700209
Why was it 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 should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
GTIN 00195278679284, Serial Numbers: SWT25250001TA, SWT25360001TA, SWT25360002TA, SWT24090006TA, SWT25100001TA, SWT25120002TA, SWT24140007TA, SWT24150008TA, SWT25100004TA, SWT24050001TA, SWT25110003TA, SWT24180011TA, SWT25120003TA, SWT25230001TA, SWT25230002TA, SWT25110009TA, SWT25110010TA, SWT25230003TA, SWT25230005TA, SWT25230006TA, SWT25230004TA, SWT25260001TA, SWT31240012TA.
Distribution
US: MI, NY and Australia, Czech Republic, Finland, Germany, Italy, Netherlands, Qatar, Saudi Arabia, Switzerland, United Arab Emirates, United Kingdom.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-3036-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.