GE Healthcare Portrait Core software recalled for vulnerability risk
GE Healthcare is recalling Portrait Core Services software version 1.2.0 because a software vulnerability may allow unauthorized persons to gain privileged access to the device. This could result in loss of patient monitoring, missed patient alarms, or access to protected health information. No injuries have been reported.
From the FDA notice · Read the official notice ↗ · All GE recalls
What to do
- Contact GE Healthcare and your care team about this patient monitoring system before changing how it is used; the notice does not list a fix or workaround.
- Check that the device is REF 5700592 with software V 1.2.0, and compare its lot or serial number with the list in the FDA notice (11 units, including SWT25510001TA and 3M1D391215).
- The notice does not say how to get a remedy; ask GE Healthcare for next steps.
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- GE Healthcare Portrait Core Services SW V 1.2.0, REF 5700592. patient monitoring system
- Sold in
- Nationwide
- Made for
- All ages (under 100 years)
Details
- Units affected
- 11 units
- Illnesses reported
- None reported
- Manufactured in
- 3114 N Grandview Blvd, Waukesha, WI, United States
- Classification
- Class II
- Recall number
- Z-2878-2026
In the FDA's words
- Description
- 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). GTIN 00198953056752, Lot/Serial Numbers: SWT25510001TA, 3M1D391215, 3M1D411081, 3M1D411083, 3M1D3B100D, SWT26110010TA, SWT26070001TA, SWT26120008TA, 3M1D411080, 3M1D411082, 3M1D3B100C. Distribution: Worldwide - US Nationwide distribution in the state of MI, and the countries of Czech Republic, Finland, Germany, Netherland, Qatar, UAE. Affected quantity: 11 units
- 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).
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