Fresh Recalls

FDAClass II · Medical device · Recall Z-3276-2026 · Recalled October 7, 2026

Philips IntraSight Plus REF recall — Volcano Corp

Agency report date: October 7, 2026.

1. Compare your item

This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.

Product named
Philips IntraSight Plus REF
Company / brand
Volcano
Lot / serial / date codes
UDI: REF: 797423:(01)00845225012946/REF:797417: (01)00845225012939 all Philips IntraSight Plus Systems with Software Version 6.0.4
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.
Agency product description and boundaries

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

Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.

If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.

2. Agency hazard and consumer action

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

No consumer remedy instructions are supplied in this record. Check the official notice and listed company contact for the agency’s current instructions.

Class II: may cause temporary or medically reversible health consequences.

Affected product: Philips IntraSight Plus REF recall status

3. Open the official notice or contact

Official recall ID
Z-3276-2026
Brand
All Volcano recalls
Classification
Class II
Units affected
19 systems
Recall status
Ongoing
Initiated
Voluntary: Firm initiated

Affected products

Companies & origin

Recalling firm location
San Diego, CA, United States
Firm address
3721 Valley Centre Dr Ste 500, 92130-3328

Identifying details (verbatim from the notice)

Product codes / lots
UDI: REF: 797423:(01)00845225012946/REF:797417: (01)00845225012939 all Philips IntraSight Plus Systems with Software Version 6.0.4
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.
Firm notified the public via
Letter
FDA event ID
99730
Recall initiated
August 6, 2026
FDA classified
September 25, 2026
FDA report date
October 7, 2026

Other medical device recalls from around the same time

Verify with the official sources:

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Source: U.S. Food & Drug Administration. Agency excerpts come from the public data feed and may omit tables or later changes; the linked government source is authoritative. Source last checked October 22, 2026 at 6:00 PM UTC. Record retrieved October 22, 2026 at 6:00 PM UTC.

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