Use cautionMedical device recall · FDA · Published August 6, 2026
Philips IntraSight Plus Software Error May Cause Wrong Patient Diagnosis
Philips IntraSight Plus systems with software version 6.0.4 may link patient records incorrectly, risking wrong diagnoses. Affected units sold worldwide since 2026.
“Philips IntraSight Plus Software Error May Cause Wrong Patient Diagnosis.” GovInfoNow, updated October 14, 2026. https://govinfonow.com/recall/1449433-volcano-corp-recalls-philips-intrasight-plus-ref-797423-and-797417. Based on FDA recall #Z-3276-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3276-2026%22&limit=1).
The FDA announced on 2026-08-06 that Volcano Corp is recalling Philips IntraSight Plus systems due to a software hazard that may associate image data from one patient with another's record. This error potentially results in incorrect diagnosis or treatment for the affected units.
How to tell if you have it
Philips IntraSight Plus REF: 797423 and 797417 100-120v-220-240v,50/60hZ, 1000 VA
UPC 00845225012939
UPC 00845225012946
Software Version 6.0.4
The hazard
The software system may associate image data from one patient with another patient's record, potentially resulting in incorrect diagnosis or treatment. The FDA said this hazard exists in all Philips IntraSight Plus Systems with Software Version 6.0.4.
Context
GovInfoNow's records show Volcano Corp has had 5 other recalls since 2022-01-24, including a 2025-06-13 recall of the Volcano Visions Digital IVUS Catheter for entanglement risks and a 2022-05-16 Philips OmniWire Pressure Guide Wire Recall for failed sterilization. Other recent recalls of similar products include GE Healthcare Centricity Enterprise Archive V2/V3/V4 Software Recall (2026-07-31) and GE Healthcare Enterprise Archive V8 Software Recall (2026-07-31), both citing patient data mismatch risks.
How to tell if you have this one
Check for the model numbers REF: 797423 or REF: 797417 on the device label. Systems with software version 6.0.4 are affected.
Brand
Volcano Corp
Product
Philips IntraSight Plus REF: 797423 and 797417 100-120v-220-240v,50/60hZ, 1000 VA
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Software Version
Verify the software version on your Philips IntraSight Plus system. If it is 6.0.4, it is affected.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 6 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “Worldwide - US Nationwide distribution in the states of MA, MN, TX, AL, GA, CA and the countries of Belgium, Denmark, Germany, Netherlands, Poland, Spain, Sweden, United Kingdom.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, California, Georgia, Massachusetts, Minnesota, Texas.
Recall timeline
FDA published this recall 2 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4Added to GovInfoNow
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-3276-2026 (August 6, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3276-2026 to see it in context.
Plain-language summary written by qwen3:4b on October 14, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.