VersanaRecalls & reported problems across all models
GE Medical Systems (China) Co.,Ltd. · 4 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one Versana model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 1
We found 4 models of Versana by GE Medical Systems (China) Co.,Ltd. in the FDA's device registry (GUDID). None of them is named in an adverse event report in our data.
1 FDA recall record name at least one of these models by its device identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Versana recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- May 16, 2025Open, Classified
GE HealthCare has become aware that the Estimated Fetal Weight (EFW) measurement data feature on the Versana Premier R3 and LOGIQ F R3 series ultrasound systems can display previous obstetric patient data in the Whizz report. This could potentially lead to an incorrect clinical decision due to inaccuracy in the fetal size and growth calculation.
Z-2030-2025 · Root cause: Software design (manufacturing process) · names 4 of these models · Recall details · FDA record ↗
Versana models
4 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Versana Premier R3 VSTransducer, ultrasonic, diagnostic1 recall0 reports
- Versana Premier R3 VASystem, imaging, pulsed doppler, ultrasonic1 recall0 reports
- Versana Premier LOTUS 4PPSystem, imaging, pulsed echo, ultrasonic1 recall0 reports
- Versana Premier LOTUS 5PPTransducer, ultrasonic, diagnostic1 recall0 reports
Other GE Medical Systems (China) Co.,Ltd. products
All GE Medical Systems (China) Co.,Ltd. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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