FDA Medical Device Recalls (openFDA)
Volcano Corp: Philips IntraSight Plus REF: 797423 and 797417 100-120v-220-240v,50/60hZ, 1000 VA
- Recall number
- Z-3276-2026
- Recalling firm
- Volcano Corp
- Product
- Philips IntraSight Plus REF: 797423 and 797417 100-120v-220-240v,50/60hZ, 1000 VA
- Status
- Open, Classified
- Initiated
- 2026-08-06
- Posted
- 2026-09-25
- Terminated
- not on file
- Reason
- Software system may associate image data from one patient with another patient's record, potentially resulting in incorrect diagnosis or treatment.
- 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
- 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.
- Lot, serial or model codes
- UDI: REF: 797423:(01)00845225012946/REF:797417: (01)00845225012939 all Philips IntraSight Plus Systems with Software Version 6.0.4
- 510(k) numbers
- ["K253714"]
- PMA numbers
- not on file
- Product code
- IYO
- Firm FEI
- 3008363989
- Firm city
- San Diego
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28