Z-0176-2019 Class II Terminated
FDA device recall Z-0176-2019 was initiated by Terumo Cardiovascular Systems Corporation on Sep 13, 2018 and is designated Class II. Reason for recall: The service manual was not updated at the time of the release of software version 1.30. The recall status is terminated (terminated Nov 18, 2019). Affected quantity: 152.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 24, 2018
- Initiation Date
- Sep 13, 2018
- Termination Date
- Nov 18, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 152
Product Description
Reason for Recall
Distribution Pattern
US Nationwide in the states of: AL, AZ, CA, CO, CT, FL, GA, IL, IN, KS, KY, MI, MN, MO, OH, OR, PA, SC, TN, TX, WA, WI, and Puerto Rico. The products were distributed to the following foreign countries: Antioquia, Australia, Bangkok, Bangladesh, Belgium, Canada, Chile, China, Columbia, Dominican Republic, Ecuador, El Salvador, France, Germany, Guatemala, India, Indonesia, Japan, Korea, Kuwait, Malaysia, Metro Manilla, Mexico, New Delhi, New Zealand, Panama, Philippines, Singapore, South Africa, Sri Lanka, Taiwan, Thailand, and Vietnam.
Code Information
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0176-2019
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026