FDA Medical Device Recalls (openFDA)
Volcano Corp: IntraSight Mobile IVUS Systems, Model: 797415, Part numbers: 300002018101, 300002018102
- Recall number
- Z-0901-2022
- Recalling firm
- Volcano Corp
- Product
- IntraSight Mobile IVUS Systems, Model: 797415, Part numbers: 300002018101, 300002018102
- Status
- Open, Classified
- Initiated
- 2022-01-24
- Posted
- not on file
- Terminated
- not on file
- Reason
- 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
- 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: igtd.remotesupport@philips.com, Hours of Operation: Monday - Friday 8:00AM - 5:00PM PST
- Quantity
- 47
- Distribution
- US: CO, GA, MA, TX, AZ, NY, PA, CA, FL, MO, OR, MD, NC, TN OUS: JP, DE, GB, NL, IT
- Lot, serial or model codes
- All MM-TSM units, Device Identifier (DI): 00845225012915
- 510(k) numbers
- ["K203719"]
- PMA numbers
- not on file
- Product code
- IYO
- Firm FEI
- 3008363989
- Firm city
- San Diego
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28