Recall Z-0430-2021 · PJB Catheter Remote Control System
Stereotaxis Inc
Niobe ES System, Models 001-006000-1 and 001-006100-1
| Date | Sep 21, 2020 |
| Status | Terminated |
| Reason | There is a potential for fire in the inside computer cabinet. |
| Root cause | Device Design |
| Action | The firm will be contacting consignees via email and providing an electronic Urgent Field Safety Notice and Customer Reply Form. Consignees are asked for return the acknowledgement form to the firm within 30 days of receipt. |
| Quantity | 121 |
| Distribution | US and OUS distribution: US - TN, MI, MN, KY, MO, IN, TX, NM, CA, NE, OH, NJ, CT, KS, OR, WA, WI, FL, IL, UT, PA, AZ, NY, GA, ID, OK, CO, LA OUS - EU, China, Australia, Singapore, Canada, South Africa, and Japan |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K192775 | Niobe® Magnetic Navigation System (MNS) with Navigant Workstation (NWS) and Cardiodri Stereotaxis, Inc., Oct 30, 2019 |