Drugs & medicalClass II

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

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

Read the official notice →
Date
2026-10-07
Country
United States
Brand
Volcano
Product
Philips IntraSight Plus REF: 797423 and 797417 100-120v-220-240v,50/60hZ, 1000 VA
Classification
Class II
Units
Worldwide - US Nationwide distribution in the states of MA, MN, TX, AL, GA, CA…
Category
Drugs & medical
Source
FDA · Device

Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer

What to do

  1. Check the product name, strength and lot number against the official notice.
  2. Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
  3. Ask the pharmacy or supplier about a replacement or refund.

General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.

More Volcano recalls

  1. 2025-08-06
  2. US
    Drugs & medicalClass II

    Volcano Corp recalls Volcano Visions Digital IVUS Catheter: PV.014P (Platinum), REF:85910P; PV.014P RX, REF: 014R; and PV.018, REF: 86700, 86700J used with…

    Reports of IVUS catheter and guide wire entanglement during radial-to-peripheral procedures, due to catheter use without appropriate sheath and/or guide catheter, which may require further intervention, such as…

    FDA · DeviceVolcano CorpWorldwide distribution - US Nationwide distribution including in the states of…Official notice →
  3. 2022-07-06
  4. US
    Drugs & medicalClass III

    Volcano Corp recalls Volcano Visions PV. 035 Digital IVUS Catheter REF 88901, PN: 300005384002 Rx Only, Sterile EO, CE 2797

    Digital IVUS catheter instructions for use ( IFU) do not contain contrainidications

    FDA · DeviceVolcano CorpWorldwide distribution - US Nationwide distribution in the states of NY, CA,…Official notice →
  5. 2022-06-22
  6. US
    Drugs & medicalClass II

    Volcano Corp recalls Philips OmniWire Pressure guide wire REF 89185J PN 300000252891

    Due to a potential failed sterilization process.

    FDA · DeviceVolcano CorpU.S.: WA and WI O.U.S.: CanadaOfficial notice →
  7. 2022-04-20
  8. US
    Drugs & medicalClass III

    Volcano Corp recalls MM-TSM (Touch Screen Module/Secondary Controller/Bedside Controller), Part Numbers: 300002018101, 300002018102, used with IntraSight…

    Multi-Modality Touch Screen Modules (MM-TSM), used with integrated IVUS systems, may crack, or become damaged, which may affect their usability. They could become non-functional. Therefore, bottom protective beams will…

    FDA · DeviceVolcano CorpUS: AZ, IL, NV, MI, FL, NC, AK, PA, WI, MN, CA, AR, NJ, TX, OR, NM, SD, CO,…Official notice →
  9. US
    Drugs & medicalClass III

    Volcano Corp recalls IntraSight Mobile IVUS Systems, Model: 797415, Part numbers: 300002018101, 300002018102

    Multi-Modality Touch Screen Modules (MM-TSM), which are bedside/secondary control units, used as part of Mobile IVUS systems, are missing the following labeling information: Unique Device Identifier, Legal Manufacturer…

    FDA · DeviceVolcano CorpUS: CO, GA, MA, TX, AZ, NY, PA, CA, FL, MO, OR, MD, NC, TN OUS: JP, DE, GB,…Official notice →
  10. 2022-04-13
  11. US
    Drugs & medicalClass II

    Volcano Corporation recalls SyncVision Systems, Model: 400-0100.10, PN: 30000485688x, with software version 4.2.x

    If FFR measurement(s) are made prior to an iFR/FFR co-registration/pullback in the same procedural session, this could result in incorrect iFR/FFR Co-Registration results to be displayed, that may cause users to…

    FDA · DeviceVolcano CorporationUS: WI, CA, CO, MO, ID, DC, LA, VA, KS, OK, GA, KY, IL, AZ, NY, IN, FL, TX,…Official notice →
All 7 Volcano recalls →

Other drugs & medical recalls in the United States

  1. 2026-10-07
  2. US
    Drugs & medicalClass II

    American Contract Systems Inc recalls Medical convenience kits containing BD CliniClean Pericare Wipes within BD Urinary Catheter Trays ABDOMINAL HYSTERECTOMY - 205989…

    Kits contain manufacturer-recalled perineal care (pericare) wipes within urinary catheter trays, which may be contaminated with a lubricant used during the manufacturing process. Use of a contaminated wipe may lead to…

    FDA · DeviceAmerican Contract Systems IncUS Nationwide distribution in the states of Iowa, Minnesota, Wisconsin, and…Official notice →
  3. US
    Drugs & medicalClass II

    American Nitrile Operations Llc recalls Brand Name: Performance Pro Product Name: Performance Pro Model/Catalog Number: 72-RM50601,72-RM50602, 72-RM50603,72-RM50604…

    Gloves may exhibit defects such as tears, missing fingers, and debris. Use of defective gloves may lead to healthcare personnel and patient exposure to infectious pathogens leading to infection or cross-contamination,…

    FDA · DeviceAmerican Nitrile Operations LlcUS Nationwide distribution.Official notice →
  4. US
    Drugs & medicalClass II

    Shanghai United Imaging Healthcare Co., Ltd. recalls Computed Tomography X-ray System, Model: uCT 530 with software

    Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are merged into a single study, that prevents patient images…

    FDA · DeviceShanghai United Imaging Healthcare Co., Ltd.US Nationwide distribution in the states of CA, PR, UT, WV, ND, NE, NC, TX,…Official notice →
  5. US
    Drugs & medicalClass II

    Bard Peripheral Vascular Inc recalls EnCor EnCompass Breast Biopsy and Tissue Removal System Console (model number: ENCPCONSOLE) and Driver (model number: ENCPDRIVER)…

    Breast biopsy and tissue removal system may experience the following errors: 1) Probe calibration and /or handheld driver failure (code HH01-00020009) , 2) Pressure sensor (code E01-0054000E), which prompts the user to…

    FDA · DeviceBard Peripheral Vascular IncUS Nationwide distribution in the states of KS, SC, CA, TX, GA, NC, PA, SC,…Official notice →
  6. US
    Drugs & medicalClass II

    Alere San Diego, Inc. recalls Fisher Scientific Sure-Vue Serum/Urine hCG, Model/ Part: FHC-202/23900529, FHC-202/23900528; Beckman Coulter Inc's ICON 25 hCG, Model/…

    hCG rapid tests may detect low levels of hCG below the stated assay sensitivity, which may result in false positive result.

    FDA · DeviceAlere San Diego, Inc.Worldwide - US Nationwide distribution including in the states of IL, PA, FL,…Official notice →
  7. US
    Drugs & medicalClass III

    HeartSine Technologies Ltd recalls HeartSine samaritan PAD (Public Access Defibrillator); HeartSine SAM 350P 350P US Device, US English - 2 Min CPR UDI-DI codes:…

    Products were distributed without the required Maintenance Supplement, which describes an extra check every 3 months in addition to the monthly check.

    FDA · DeviceHeartSine Technologies LtdU.S. Nationwide distribution including in the states of AL, AR, AZ, CA, CO,…Official notice →
See all drugs & medical recalls →