Class II — GE Medical Systems Information Technologies Inc
| Recalling firm | GE Medical Systems Information Technologies Inc |
|---|---|
| Classification | Class II |
| Status | Ongoing |
| 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). |
| Product | GE Healthcare Portrait Core Services SW V 1.2.0, REF 5700592. patient monitoring system |
| Quantity | 11 units |
| Distribution | Worldwide - US Nationwide distribution in the state of MI, and the countries of Czech Republic, Finland, Germany, Netherland, Qatar, UAE. |
| Initiated | 2026-07-10 |
| Classified | 2026-08-04 |
| Recall number | Z-2878-2026 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — GE Medical Systems Information Technologies Inc (Z-2878-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/99475/
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