IntraSight PlusRecalls & reported problems across all models
Philips Image Guided Therapy Corporation · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one IntraSight Plus 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 2 models of IntraSight Plus by Philips Image Guided Therapy Corporation 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
IntraSight Plus 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.
- Aug 6, 2026Open, Classified
Software system may associate image data from one patient with another patient's record, potentially resulting in incorrect diagnosis or treatment.
Z-3276-2026 · Root cause: Software Design Change · names 2 of these models · Recall details · FDA record ↗
IntraSight Plus models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- IntraSight Plus 797417System, Imaging, Pulsed Echo, Ultrasonic1 recall0 reports
- IntraSight Plus 797423System, Imaging, Pulsed Echo, Ultrasonic1 recall0 reports
Other Philips Image Guided Therapy Corporation products
- OmniWire Pressure guide wire2 models · 191 reports · 2 recalls
- Visions PV .014P RX Digital IVUS Catheter2 models · 90 reports · 1 recall
- Visions PV .035 Digital IVUS Catheter2 models · 32 reports · 2 recalls
- Pioneer Plus Catheter2 models · 64 reports
- Verrata Plus Pressure Guide Wire2 models · 45 reports
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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