Z-0917-2022Class III

MM-TSM (Touch Screen Module/Secondary Controller/Bedside Controller), Part Numbers: 300002018101...

Name: Z-0917-2022 MM-TSM (Touch Screen Module/Secondary Controller/Bedside Controller), Part Numbers: 300002018101...
Creator: Volcano Corp
Published: 2022-02-03
License: https://open.fda.gov/license/

Volcano Corporation / initiated 2022-02-03 / Open, Classified / root cause: design

FDA source

Volcano Corp began a recall of MM-TSM (Touch Screen Module/Secondary Controller/Bedside Controller), Part Numbers: 300002018101, 300002018102, used with IntraSight Integrated (Part Number... on 2022-02-03. FDA classified it as Class III and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0917-2022
Classification: Class III
Status: Open, Classified
Initiated: 2022-02-03
Posted: 2022-04-12
Recalling firm: Volcano Corporation
Product: MM-TSM (Touch Screen Module/Secondary Controller/Bedside Controller), Part Numbers: 300002018101, 300002018102, used with IntraSight Integrated (Part Number: 797403) IVUS systems
Product code: DSA Cable, Transducer And Electrode, Patient, (Including Connector)
Reason for recall: 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 be replaced with full protective metal brackets.
Root cause tag: design
FDA root cause: Device Design
Action: On 02/03/22, correction notices were sent to customers who were asked to do the following: Notify all affected system users within the facility of this recall. The updated bracket improves protection on all sides of the MM-TSM touch screen that will prevent issues, cosmetic concerns, and maintain device integrity. If you are a distributor or have forwarded affected device(s) to another end user, it is imperative that all end-users with affected devices receive this Important Product Notice. Complete and return the customer response form. Customers with additional questions are encouraged to contact their local recalling firm representative or 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: 1358
Distribution: US: AZ, IL, NV, MI, FL, NC, AK, PA, WI, MN, CA, AR, NJ, TX, OR, NM, SD, CO, KY, LA, DE, MA, MT, MO, VA, AL, NY, WV, SC, IN, GA, IA, OH, UT, NH, MS, TN, OK, ID, MD, HI, RI, WY, DC, WA, KS, NE, ND, CT, VT. OUS: SK, IT, DK, GB, DE, SE, IN, KW, QA, PL, NL, CL, JP, BE, AU, FR, PF, PT, NZ, CA, ES, PK, CY, AT, IL, IE, CH, GR, SA, PS, LB, HK, IS, TH, AR, OM, AE, NO, ID, RO, RS, MM, ZA, SG
Product codes and lots: MM-TSMs with bottom protective beams

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0917-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0917-2022	Class III	Ongoing	Voluntary: Firm initiated	2022-04-20	2022-04-12

Product code DSA

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)