Z-0674-2020 Class II Terminated
FDA device recall Z-0674-2020 was initiated by Volcano Corporation on November 7, 2018 and is designated Class II. Reason for recall: Interoperability issue that affects certain systems that use the recalled software when it is connected to specific Hemodynamic Systems (HMS). The recall status is terminated (terminated July 14, 2022). Affected quantity: 3,667 units with software.
Recall Details
- Product Type
- Devices
- Report Date
- December 18, 2019
- Initiation Date
- November 7, 2018
- Termination Date
- July 14, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3,667 units with software
Product Description
Reason for Recall
Distribution Pattern
Distribution was nationwide. There was government/military distribution. Foreign distribution was made to Canada, Austria, Australia, Badajoz, Bahrain, Belgium, Brazil, Bulgaria, Chile, China, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Iceland, India, Ireland, Israel, Italy, Jordan, Japan, Korea, Republic of, Lebanon, Lithuania, Malaysia, Malta, Mexico, Netherlands, New Zealand, Norway, Pakistan, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Serbia, Sierra Leone, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, and United Kingdom.