Recall Z-2878-2026— GE Medical Systems Information Technologies Inc
Class II · Ongoing
Class II FDA medical device recall by GE Medical Systems Information Technologies Inc, initiated 2026-07-10. It names one FDA 510(k) clearance: K234130. Product: GE Healthcare Portrait Core Services SW V 1.2.0, REF 5700592. patient monitoring system. Reason: 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)..
- Recalling firm
- GE Medical Systems Information Technologies Inc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2026-07-10
- Firm location
- Waukesha, WI, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
GE Healthcare Portrait Core Services SW V 1.2.0, REF 5700592. patient monitoring system
Reason for recall
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).
Data sourced from openFDA. This site is unofficial and independent of the FDA.