FDA recall Z-0901-2022

Volcano Corp · Class III · device

Product

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

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.

Distribution

US: CO, GA, MA, TX, AZ, NY, PA, CA, FL, MO, OR, MD, NC, TN OUS: JP, DE, GB, NL, IT

Key facts

Status: Ongoing
Initiation date: 2022-01-24
Report date: 2022-04-20
Voluntary/Mandated: Voluntary: Firm initiated
Location: San Diego, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0901-2022