Z-0901-2022Class III

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

Name: Z-0901-2022 IntraSight Mobile IVUS Systems, Model: 797415, Part numbers: 300002018101, 300002018102
Creator: Volcano Corp
Published: 2022-01-24
License: https://open.fda.gov/license/

Volcano Corporation / initiated 2022-01-24 / Open, Classified / root cause: labeling and UDI

FDA source

Volcano Corp began a recall of IntraSight Mobile IVUS Systems, Model: 797415, Part numbers: 300002018101, 300002018102 on 2022-01-24. FDA classified it as Class III and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0901-2022
Classification: Class III
Status: Open, Classified
Initiated: 2022-01-24
Posted: 2022-04-09
Recalling firm: Volcano Corporation
Product: IntraSight Mobile IVUS Systems, Model: 797415, Part numbers: 300002018101, 300002018102
Product code: IYO System, Imaging, Pulsed Echo, Ultrasonic
Reason for recall: 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 Information, Part Number, Rx Symbol, and Model Reference Information.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: On 01/24/22, correction notices were sent to customers who were informed that the recalling firm will notify all affected customers and arrange for a Field Service Engineer (FSE) to replace the MM-TSM free of charge. In addition, customers were asked to do the following: 1) Distributors or customers who have forwarded affected devices to other end users were asked to, send a copy of the correction notification to any customer to whom they have distributed affected devices to. 2) Customers were asked to complete and return customer response forms. 3) Customers with additional questions were encouraged to contact their local firm representative or contact IGTD Customer Service: Phone: 1-800-228-4728, Option 2, Email: [email protected], Hours of Operation: Monday - Friday 8:00AM - 5:00PM PST
Quantity in commerce: 47
Distribution: US: CO, GA, MA, TX, AZ, NY, PA, CA, FL, MO, OR, MD, NC, TN OUS: JP, DE, GB, NL, IT
Product codes and lots: All MM-TSM units, Device Identifier (DI): 00845225012915

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0901-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0901-2022	Class III	Ongoing	Voluntary: Firm initiated	2022-04-20	2022-04-08

Product code IYO

K203719Class IIIntraSight MobileVolcano Corporation / cleared 2021-01-19

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)