Recall
FDAHealthJuly 10, 2026

GE Medical Systems Information Technologies Inc — GE Healthcare Portrait Core Services SW V 1.2.0, REF 5700592. patient monitoring system

⚠️ 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).

Is this relevant to me?

Geography
Nationwide
Source agency
FDA
Category
Health
Published
July 10, 2026

Worldwide - US Nationwide distribution in the state of MI, and the countries of Czech Republic, Finland, Germany, Netherland, Qatar, UAE.

What's affected?

Product
GE Healthcare Portrait Core Services SW V 1.2.0, REF 5700592. patient monitoring system
Lot code
/Serial

Additional details

GTIN 00198953056752, Lot/Serial Numbers: SWT25510001TA, 3M1D391215, 3M1D411081, 3M1D411083, 3M1D3B100D, SWT26110010TA, SWT26070001TA, SWT26120008TA, 3M1D411080, 3M1D411082, 3M1D3B100C.

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: 11 units.

View original FDA notice →

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