IntraSight Mobile IVUS Systems, Model: 797415, Part… recallZ-0901-2022 · Volcano Corp · initiated Jan 24, 2022
Class III Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Volcano Corp or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Error in labeling
What the company is doing
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
Recall details
- Recall number
- Z-0901-2022
- Recall class
- Class III
- Status
- Open, Classified
- Initiated by the company
- Jan 24, 2022
- Recalling firm
- Volcano Corp
- Quantity
- 47
- Product code
- IYO
- FDA submissions
- K203719
- Distribution
- US: CO, GA, MA, TX, AZ, NY, PA, CA, FL, MO, OR, MD, NC, TN OUS: JP, DE, GB, NL, IT
Product description
IntraSight Mobile IVUS Systems, Model: 797415, Part numbers: 300002018101, 300002018102
Code information (models, lots, serial numbers)
All MM-TSM units, Device Identifier (DI): 00845225012915
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- IntraSight Mobile System 797415Philips Image Guided Therapy Corporation · System, Imaging, Pulsed Echo, Ultrasonic1 recall62 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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