FDA-Device2025-12-24Class IIPROCESSING DEFECT
GE HealthCare ViewPoint 6 ultrasound software recalled for incomplete patient history
What this means
GE HealthCare ViewPoint 6 versions 6.15.3 and 6.15.4 may not display complete patient medical history information in the Patient History tab. This affects specific ultrasound systems used in medical facilities. No injuries have been reported.
- Contact GE HealthCare if your facility uses ViewPoint 6 version 6.15.3 or 6.15.4
- Check your system ID number against the recall list
- Update to the corrected software version when available
- Verify patient history information from alternative records until the update is applied
The agency's original wording
Hazard
GE HealthCare has become aware that the Patient History tab in ViewPoint 6 versions 6.15.3 and 6.15.4 ultrasound software may not include complete patient medical history information.
Intended for
Adults
Illnesses reported
None reported
Sold states
Worldwide
Affected count
1221 units
Manufactured in
Oskar-Schlemmer-Str. 11, Munich, Germany
Products
GE HealthCare ViewPoint 6, Catalog Number H47601AA; Radiological image processing system
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0935-2026Want us to check the next one for you?
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