PORTRAIT CORE SERVICES SOFTWARE V1 — Class II medical device recall Z-3038-2026
Ongoing recall by GE Medical Systems Information Technologies Inc, reported 2026-09-02, distributed in MI, NY. Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. In addition, all alar
| Recall number | Z-3038-2026 |
|---|---|
| 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 | 2026-07-20 |
| Classified | 2026-08-27 |
| Reported by FDA | 2026-09-02 |
| Distributed | MI, NY |
| Countries outside the US | AE, AU, CH, CZ, DE, FI, GB, IT, NL, QA, SA |
| Quantity | 15 units |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00195278364838 |
| Serial numbers | SUC23080050TA, SUD22280002TA, SUD22420001TA, SUD22470001TA, SUD22470003TA, SUD22470004TA, SUD22470005TA, SUD22470009TA, SUD22470010TA, SUD23390001TA, SUD23390003TA, SUD23390004TA, SUD23390005TA, SUD23390009TA, SUD23390010TA |
| Model numbers | 5697353 |
Product
PORTRAIT CORE SERVICES SOFTWARE V1.0.5, Ref# 5697353
Reason for recall
Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. In addition, all alarm settings could be reset to factory defaults following the update and will not follow the alarm settings previously configured for each patient or care area.
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-3038-2026. 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.