Portrait Core Services — Class II medical device recall Z-0918-2025
Ongoing recall by GE Medical Systems, LLC, reported 2025-01-22, distributed nationwide. There is a software issue that can result in the loss of patient monitoring on the Portrait Central Viewer App
| Recall number | Z-0918-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Medical Systems, LLC, Waukesha, WI, United States |
| Recall initiated | 2024-12-06 |
| Classified | 2025-01-15 |
| Reported by FDA | 2025-01-22 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AU, CN, CZ, FR, GB, IT, NL, QA, SG |
| Quantity | 7 systems |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00195278659446 |
| Serial numbers | 6399074-7, 6399074-8, 6399074-9, 6399326-1, 6399326-2, SWT24040001TA, SWT24050001TA, SWT24060001TA, SWT24090006TA, SWT24150008TA, SWT24180009TA, SWT24180010TA, SWT24180011TA, SWT24340007TA, SWT24360002TA, SWT24370001TA, SWT24370002TA, SWT31240012TA |
Product
Portrait Core Services, a set of software services that enable the communication and interaction of the Portrait Mobile Monitoring Solution components and will integrate into existing healthcare facility infrastructure and clinical information systems, Model CSSXB
Reason for recall
There is a software issue that can result in the loss of patient monitoring on the Portrait Central Viewer Application after 425 days of continuous run-time.
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-0918-2025. 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.