Recall Z-0260-2025 ยท OWB Interventional Fluoroscopic X-Ray System
Trackx Technology Inc
Product Name: Insight Base Flex - 8, Ref 608-3TX; The device consists of a sterile Snap that includes reflective features that facilitate imaging of the (attached) instrument using instrument tracking technology when used with a compatible tracking system. Each TrackX Snap has a unique set of 2 or more reflective markers. By having unique configurations of reflective markers, it is possible to ide
| Date | Oct 30, 2024 (initiated Sep 3, 2024) |
| Status | Open, Classified |
| Reason | The patient label stickers may have the wrong expiration date recorded. The contract manufacturer entered the manufacturing date (2024-04-01) as the expiration date. The actual expiration date of the product is 2027-04-01. This is reflected on the carton label and sterile pouch label correctly. |
| Root cause | Error in labeling |
| Action | TrackX Technology issued an Urgent: Medical Device Field Correction notice to its consignees via hand delivery by their sales representatives on 10/01/2024. The notice explained the issue and requested that the notice be provided to all parties to whom the product was distributed. The sales representatives exchanged the affected product for correctly labeled product. |
| Quantity | 82 |
| Distribution | NC, VA, FL, PA, NY |
| FDA record | Open on fda.gov |