FDAFDA · Food and drugs·Recall number Z-2878-2026
GE Healthcare Portrait Core Services SW V 1.2.0, REF 5700592. patient monitoring system
Published August 12, 2026 · Recall initiated: July 10, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
A software vulnerability may allow unauthorized persons to gain privileged access to the device, which could result in loss of patient monitoring, missed patient alarms, and/or access to Protected Health Information (PHI).
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- GE Medical Systems Information Technologies Inc
- Distributor
- Worldwide - US Nationwide distribution in the state of MI, and the countries of Czech Republic, Finland, Germany, Netherland, Qatar, UAE.
- Lot
- GTIN 00198953056752, Lot/Serial Numbers: SWT25510001TA, 3M1D391215, 3M1D411081, 3M1D411083, 3M1D3B100D, SWT26110010TA, SWT26070001TA, SWT26120008TA, 3M1D411080, 3M1D411082, 3M1D3B100C.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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