Volcano Corp recalls Philips IntraSight Plus REF: 797423 and 797417 100-120v-220-240v

Software system may associate image data from one patient with another patient's record, potentially resulting in incorrect diagnosis or treatment.

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.

• FDA enforcement recordOfficial FDA database entry for Z-3276-2026
• FDA 510(k) clearance · K253714The device's official FDA premarket clearance record
• FDA device classification · IYOOfficial FDA classification for this device type
• CFR regulation · 21 CFR 892.1560The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Volcano CorpSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.