INNOVARecalls & reported problems across all models
Ge Medical Systems · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
2 open recalls name at least one INNOVA 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
- 2
We found 2 models of INNOVA by Ge Medical Systems in the FDA's device registry (GUDID). None of them is named in an adverse event report in our data.
2 FDA recall records name at least one of these models by its device identifier, 2 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
INNOVA 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.
- Mar 18, 2024Open, Classified
GE HealthCare has become aware of the potential that adhesive material might not have been applied to some bolts of certain Innova IGS, Discovery IGS, Interact IGS, Allia IGS and Allia Pulse IGS products. This could result in a potential fall of the Detector/Elevator or X-ray tube of the frontal Gantry assembly.
Z-1778-2024 · Root cause: Process control · Recall details · FDA record ↗
- Mar 18, 2024Open, Classified
GE HealthCare has become aware of the potential that adhesive material might not have been applied to some bolts of certain Innova IGS, Discovery IGS, Interact IGS, Allia IGS and Allia Pulse IGS products. This could result in a potential fall of the Detector/Elevator or X-ray tube of the frontal Gantry assembly.
Z-1777-2024 · Root cause: Process control · Recall details · FDA record ↗
INNOVA models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- INNOVA IGS 6 001Interventional Fluoroscopic X-Ray System1 recall0 reports
- INNOVA IGS 5 001System, x-ray, fluoroscopic, image-intensified1 recall0 reports
Other Ge Medical Systems products
All Ge Medical Systems 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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