Z-1283-2022 Class II
FDA device recall Z-1283-2022 was initiated by CardioTek BV on April 25, 2022 and is designated Class II. Reason for recall: Device did not pass electrical safety testing for adequate insulation. Affected quantity: 146 units.
Recall Details
- Product Type
- Devices
- Report Date
- June 29, 2022
- Initiation Date
- April 25, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 146 units
Product Description
CardioTek EP-TRACER Software V2.x.
Reason for Recall
Device did not pass electrical safety testing for adequate insulation.
Distribution Pattern
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.
Code Information
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