Device product
IntraSight Mobile IVUS Systems, Model: 797415, Part numbers: 300002018101, 300002018102
Z-0901-2022
Product summary
- Firm
- Volcano Corp
- Event
- Event 89677
- Status
- Ongoing
- Classification
- Class III
- Quantity
- 47
- Official record key
device-enforcement:Z-0901-2022
Official wording
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.
Code information: All MM-TSM units, Device Identifier (DI): 00845225012915
Distribution pattern: US: CO, GA, MA, TX, AZ, NY, PA, CA, FL, MO, OR, MD, NC, TN OUS: JP, DE, GB, NL, IT
Derived failure modes
-
Unknown
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.