Official recall notice
FDA DeviceClass IINotable
FDA Recall: GE Healthcare Portrait Core Services SW V 1.2.0, REF 5700592. patient monitoring system
- Recall date
- 2026-08-12
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
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).
Product description
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).
Affected products
GTIN 00198953056752, Lot/Serial Numbers: SWT25510001TA, 3M1D391215, 3M1D411081, 3M1D411083, 3M1D3B100D, SWT26110010TA, SWT26070001TA, SWT26120008TA, 3M1D411080, 3M1D411082, 3M1D3B100C.