GE Healthcare Portrait Core Services SW V 1 — Class II medical device recall Z-2878-2026
Ongoing recall by GE Medical Systems Information Technologies Inc, reported 2026-08-12, distributed nationwide. A software vulnerability may allow unauthorized persons to gain privileged access to the device, which could r
| Recall number | Z-2878-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Medical Systems Information Technologies Inc, Waukesha, WI, United States |
| Recall initiated | 2026-07-10 |
| Classified | 2026-08-04 |
| Reported by FDA | 2026-08-12 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, CZ, DE, FI, QA |
| Quantity | 11 units |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00198953056752 |
| Serial numbers | 3M1D391215, 3M1D3B100C, 3M1D3B100D, 3M1D411080, 3M1D411081, 3M1D411082, 3M1D411083, SWT25510001TA, SWT26070001TA, SWT26110010TA, SWT26120008TA |
| Model numbers | 5700592 |
Product
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).
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2878-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.