IntraSight Plus recallZ-3276-2026 · Volcano Corp · initiated Aug 6, 2026
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Volcano Corp or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Software system may associate image data from one patient with another patient's record, potentially resulting in incorrect diagnosis or treatment.
FDA root cause category: Software Design Change
What the company is doing
On August 6, 2026, Philips issued a Urgent Medical Device Correction to affected consignees. Philips ask consignees to take the following actions: 1. Contact your local Philips Service representative in advance of any changes to the worklist provider, Azurion software, interface configuration, or hospital IT environment, as such changes may affect the Study ID field. Your Philips Service representative will help evaluate any impact and/or reverify as applicable. Otherwise, you may continue to use the device in accordance with the intended use. 2. Please circulate this notice to all users of the IntraSight Plus so they are aware of the issue and associated hazard / harm. Philips also encourages all customers to post this letter on or near the system until Philips has updated its software.
Recall details
- Recall number
- Z-3276-2026
- Status
- Open, Classified
- Initiated by the company
- Aug 6, 2026
- Posted by the FDA
- Sep 25, 2026
- Recalling firm
- Volcano Corp
- Quantity
- 19 systems
- Product code
- IYO
- FDA submissions
- K253714
- 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.
Product description
Philips IntraSight Plus REF: 797423 and 797417 100-120v-220-240v,50/60hZ, 1000 VA
Code information (models, lots, serial numbers)
UDI: REF: 797423:(01)00845225012946/REF:797417: (01)00845225012939 all Philips IntraSight Plus Systems with Software Version 6.0.4
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- IntraSight Plus 797417Philips Image Guided Therapy Corporation · System, Imaging, Pulsed Echo, Ultrasonic1 recall0 reports
- IntraSight Plus 797423Philips Image Guided Therapy Corporation · System, Imaging, Pulsed Echo, Ultrasonic1 recall0 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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