FDA-Device2026-10-07Class IIPROCESSING DEFECT
Philips IntraSight Plus imaging system recalled for patient image data mix-up risk
What this means
The Philips IntraSight Plus imaging system software may incorrectly link one patient's images to another patient's medical record. This could lead to wrong diagnosis or treatment if the mix-up goes unnoticed.
- Check your system software version (Version 6.0.4 is affected)
- Contact Philips technical support or your equipment vendor for guidance
- Verify patient images match the correct patient record before clinical use
- Watch for a software update from Philips to resolve this issue
The agency's original wording
Hazard
Software system may associate image data from one patient with another patient's record, potentially resulting in incorrect diagnosis or treatment.
Intended for
Adults
Illnesses reported
None reported
Sold states
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.
Affected count
19 systems
Manufactured in
3721 Valley Centre Dr Ste 500, San Diego, CA, United States
Products
Philips IntraSight Plus REF: 797423 and 797417 100-120v-220-240v,50/60hZ, 1000 VA
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3276-2026Want us to check the next one for you?
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