FDA Device recall Z-2878-2026
GE Healthcare Portrait Core Services SW V 1.2.0, REF 5700592. patient monitoring system
- FDA Device
- Class II
- ongoing
- Published 2026-08-12
On 2026-08-12 the FDA classified a Class II recall of GE Healthcare Portrait Core Services SW V 1.2.0, REF 5700592. patient monitoring system by Ge Medical Systems Information Technologies, citing 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 ac….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2878-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-07-10 |
| Published | 2026-08-12 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Ge Medical Systems Information Technologies |
| Distribution | US |
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).
Identifiers
| code_info | GTIN 00198953056752, Lot/Serial Numbers: SWT25510001TA, 3M1D391215, 3M1D411081, 3M1D411083, 3M1D3B100D, SWT26110010TA,…GTIN 00198953056752, Lot/Serial Numbers: SWT25510001TA, 3M1D391215, 3M1D411081, 3M1D411083, 3M1D3B100D, SWT26110010TA, SWT26070001TA, SWT26120008TA, 3M1D411080, 3M1D411082, 3M1D3B100C. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Other recalls by Ge Medical Systems Information Technologies
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FDA Device · Class II · 2026-09-23 · Ge Medical Systems Information Technologies - PORTRAIT COMPUTE AND CORE SERVICES V1.2, Ref# 5700592
FDA Device · Class II · 2026-09-02 · Ge Medical Systems Information Technologies - PORTRAIT CORE SERVICES SOFTWARE V1.0.5, Ref# 5697353
FDA Device · Class II · 2026-09-02 · Ge Medical Systems Information Technologies - FRU (Field replaceable unit), PORTRAIT CORE SERVICES SW RELOAD V1.1, Ref# 5700225
FDA Device · Class II · 2026-09-02 · Ge Medical Systems Information Technologies - PORTRAIT CORE SERVICES SOFTWARE V1.1, Ref# 5700209
FDA Device · Class II · 2026-09-02 · Ge Medical Systems Information Technologies
All Ge Medical Systems Information Technologies recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2878-2026%22
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