Portrait CSSXBRecalls & reported problems
GE Medical Systems Information Technologies, Inc. · PORTRAIT CORE SERVICES INSTALLATION SOFTWARE V1.1.0 · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's identifier, 1 still open.
3 other recalls cover devices cleared under the same FDA submission (K234130); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Recalls naming this device
- Dec 6, 2024Open, Classified
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.
Z-0918-2025 · Root cause: Software design · FDA record ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K234130. One submission often covers many models, so check the product and lot details in each record.
- Z-3037-2026 · Jul 20, 2026 · Open, ClassifiedPORTRAIT COMPUTE AND CORE SERVICES V1.2, Ref# 5700592
- Z-3036-2026 · Jul 20, 2026 · Open, ClassifiedPORTRAIT CORE SERVICES SOFTWARE V1.1, Ref# 5700209
- Z-2878-2026 · Jul 10, 2026 · Open, ClassifiedGE Healthcare Portrait Core Services SW V 1.2.0, REF 5700592
Other TRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQUENCY devices
- NA ORG-9110ANihon Kohden Corporation · TRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQUENCY272 reports
- NA GZ-130PNihon Kohden Corporation · TRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQUENCY1 death203 reports
- NA ORG-9100ANihon Kohden Corporation · TRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQUENCY106 reports
- Midmark Midmark Digital ECGCardioline SPA · Transmitters And Receivers, Physiological Signal, Radiofrequency1 recall1 report
- Vital Sync VITALSYNCSW03Covidien LP · TRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQUENCY1 recall1 report
- Vital Sync VITALSYNCSW03Covidien LP · TRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQUENCY1 recall1 report
- VistaCenter 6200-01Vital Connect, Inc. · Transmitters And Receivers, Physiological Signal, Radiofrequency1 recall1 report
- BioButton v3 (BBN-r, different batch) BIOST06040Biointellisense, Inc. · Transmitters And Receivers, Physiological Signal, Radiofrequency1 recall0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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