Home / Recalls / Volcano Corp / Z-0901-2022

Z-0901-2022 Class III Ongoing

Recalled by Volcano Corp — San Diego, CA

Recall Details

Product Type
Devices
Report Date
April 20, 2022
Initiation Date
January 24, 2022
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
47

Product Description

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 Pattern

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

Code Information

All MM-TSM units, Device Identifier (DI): 00845225012915

Other recalls by Volcano Corp

  • Z-2221-2025 Class II — Volcano Visions Digital IVUS Catheter: PV.014P (Platinum), REF:85910P; PV.014P (June 13, 2025)
  • Z-1270-2022 Class II — Philips OmniWire Pressure guide wire REF 89185J PN 300000252891 (May 16, 2022)
  • Z-1301-2022 Class III — Volcano Visions PV. 035 Digital IVUS Catheter REF 88901, PN: 300005384002 Rx Onl (May 13, 2022)
  • Z-1302-2022 Class III — Volcano Visions PV. 035 Digital IVUS Catheter REF 81234, PN: 300007367341 , Rx O (May 13, 2022)
  • Z-0917-2022 Class III — MM-TSM (Touch Screen Module/Secondary Controller/Bedside Controller), Part Numbe (February 3, 2022)
  • Z-2045-2015 Class II — ComboMap Intravascular Flow and Pressure System; Product/Part number: Combo Ma (September 23, 2013)
  • Z-2044-2015 Class II — Volcano s5i/s5ix/s5iz/CORE Intravascular Ultrasound Imaging and Pressure System (September 23, 2013)
  • Z-2043-2015 Class II — Volcano s5/s5x/CORE Mobile Intravascular Ultrasound Imaging and Pressure System; (September 23, 2013)