Recall Z-1283-2022 ยท DQK Computer, Diagnostic, Programmable
CardioTek BV
CardioTek EP-TRACER Software V2.x.
| Date | Apr 25, 2022 |
| Status | Completed |
| Reason | Device did not pass electrical safety testing for adequate insulation. |
| Root cause | Under Investigation by firm |
| Action | The firm issued a recall notification to consignees on 04/25/2022 via email. On 05/24/2022 the firm sent an updated field safety notice. The consignee can continue to use the device. The firm will contact the customer to schedule an appointment for the rework. The consignee is to pass on the letter to those that need to be made aware of the notice. |
| Quantity | 146 units |
| Distribution | 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 Arabi |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K183266 | EP-TRACER System Schwarzer Cardiotek GmbH, Mar 1, 2019 |