Data Foundry

Medical device recalls 2026

PORTRAIT COMPUTE AND CORE SERVICES V1 — Class II medical device recall Z-3037-2026

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 numberZ-3037-2026
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmGE Medical Systems Information Technologies Inc, Waukesha, WI, United States
Recall initiated2026-07-20
Classified2026-08-27
Reported by FDA2026-09-02
DistributedMI, NY
Countries outside the USAE, AU, CH, CZ, DE, FI, GB, IT, NL, QA, SA
Quantity4 units
Reason classessoftware
UPC / GTIN / UDI-DI00198953056752
Serial numbersSWT25510001TA, SWT26070001TA, SWT26110010TA, SWT26120008TA
Model numbers5700592

Product

PORTRAIT COMPUTE AND CORE SERVICES V1.2, Ref# 5700592

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-3037-2026. 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.