Z-3276-2026

Philips IntraSight Plus REF: 797423 and 797417 100-120v-220-240v,50/60hZ, 1000 VA

Name: Z-3276-2026 Philips IntraSight Plus REF: 797423 and 797417 100-120v-220-240v,50/60hZ, 1000 VA
Creator: Volcano Corp
Published: 2026-08-06
License: https://open.fda.gov/license/

Volcano Corp / initiated 2026-08-06 / Open, Classified

FDA source

Recall record

Recall number: Z-3276-2026
Status: Open, Classified
Initiated: 2026-08-06
Posted: 2026-09-25
Recalling firm: Volcano Corp
Product: Philips IntraSight Plus REF: 797423 and 797417 100-120v-220-240v,50/60hZ, 1000 VA
Product code: IYO System, Imaging, Pulsed Echo, Ultrasonic
Reason for recall: Software system may associate image data from one patient with another patient's record, potentially resulting in incorrect diagnosis or treatment.
FDA root cause: Software Design Change
Action: 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.
Quantity in commerce: 19 systems
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 codes and lots: UDI: REF: 797423:(01)00845225012946/REF:797417: (01)00845225012939 all Philips IntraSight Plus Systems with Software Version 6.0.4

Product code IYO

K253714Class IIIntraSight PlusPhilips Image Guided Therapy Corporation / cleared 2026-02-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-10-02. View this recall on fda.gov (opens on fda.gov)