Philips IntraSight Plus REF: 797423 and 797417 100-120v-220-240v,50/60hZ, 1000 VA
FDA Recall Z-3276-2026 · Posted 2026-09-25
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Recalling FirmVolcano Corp
Recall StatusOpen, Classified
Product CodeIYO
Date Initiated2026-08-06
Product Quantity19 systems
Reason for Recall
Software system may associate image data from one patient with another patient's record, potentially resulting in incorrect diagnosis or treatment.
Firm 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.
Root Cause
Software Design Change
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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