CardioTek EP-TRACER Software V2.x.
Enforcement
- Recall Number
- Z-1283-2022
- Event ID
- 90154
- Classification
- Class II
- Status
- Completed
- Product Type
- Devices
- Firm
- CardioTek BV
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Report Date
- June 29, 2022
- Initiation Date
- April 25, 2022
- Classification Date
- June 23, 2022
- Address
- Amerikalaan 70, Maastricht-Airport, N/A, Netherlands
Description
CardioTek EP-TRACER Software V2.x.
Device did not pass electrical safety testing for adequate insulation.
EP-TRACER 38 UDI/DI: 04260441455418; Serial Numbers: 2019-1-01, 2019-1-02, 2019-1-03, 2019-1-04, 2019-1-05, 2019-1-06, 2019-2-01, 2019-2-02, 2019-2-03, 2019-2-04, 2019-2-05, 2019-3-01, 2019-3-02, 2019-3-03, 2019-3-04, 2019-3-05, 2019-3-06, 2019-3-07, 2019-3-08, 2019-3-09, 2019-3-10, 2019-4-01, 2019-4-02, 2019-4-03, 2019-4-04, 2019-4-05, 2019-4-06, 2019-4-07, 2019-4-08, 2019-4-09, 2019-4-10, 2019-5-01, 2019-5-02, 2019-5-03, 2019-5-04, 2019-5-05, 2020-1-01, 2020-1-02, 2020-1-03, 2020-1-04, 2020-1-05, 2020-1-06, 2020-1-07, 2020-1-08, 2020-1-09, 2020-1-10, 2020-1-11, 2020-1-12, 2020-1-13, 2020-1-14, 2020-1-15, 2020-2-01, 2020-2-02, 2020-2-03, 2020-2-04, 2020-2-05, 2020-2-06, 2020-2-07, 2020-2-08, 2020-2-09, 2020-2-10, 2020-2-11, 2020-2-13, 2020-2-14, 2020-2-15, 2020-4-01, 2020-4-02, 2020-4-03, 2020-4-04, 2021-1-01, 2021-1-02, 2021-1-03, 2021-1-04, 2021-1-05, 2021-1-06, 2021-1-07, 2021-1-08, 2021-2-01, 2021-2-02, 2021-2-03, 2021-2-04, 2021-2-06, 2021-2-07, 2021-2-08, 2021-2-09, 2021-2-10, 2021-2-11, 2021-2-12, 2021-2-13, 2021-2-14, 2021-2-15, 2021-3-01, 2021-3-02, 2021-3-03, 2021-3-04, 2021-3-05, 2021-3-06, 2021-3-07, 2021-3-08, 2021-3-09, 2021-3-10, 2021-3-11, 2021-3-12, 2021-3-13, 2021-3-14, 2021-3-15, 2021-5-01, 2021-5-02, 2021-5-03, 2021-5-04, 2021-5-05, 2021-5-06, 2022-1-01, 2022-1-03, 2022-1-04, 2022-1-05, 2022-1-06; EP-TRACER 102 UDI/DI: 04260441455234; Serial Numbers: 2019-1-11, 2019-2-11, 2019-2-12, 2019-2-13, 2019-2-14, 2019-2-15, 2019-2-16, 2019-4-21, 2019-4-22, 2019-4-23, 2019-4-24, 2019-4-25, 2019-4-26, 2019-4-27, 2020-1-26, 2020-1-27, 2020-1-28, 2020-1-29, 2020-1-30, 2020-2-26, 2020-2-27, 2020-2-28, 2020-2-29, 2020-2-30, 2021-1-13, 2021-1-14, 2021-2-27, 2022-1-26, 2022-1-27
Worldwide distribution - US Nationwide distribution in the states of CA, NY, NC and the countries of South Korea, Mexico, Kazakhstan, Netherlands, Spain, Germany, Finland, Poland, Israel, Turkey, Chile, Ecuador, Austria, Croatia, Sweden, United Kingdom, Colombia, Italy, Portugal, Canada, Saudi Arabia, Belgium, Slovenia, Brazil, Hungary, Malaysia, Uzbekistan.
146 units