Recall Z-2269-2023 ยท JAK System, X-Ray, Tomography, Computed
Olympus Corporation of the Americas
Always-On Tip Tracked Instruments (SPiN Drive instruments) SPiN Xtend 2.0mm OD, 21ga Intended for use in clinical interventions and for anatomical structures where computed tomography and/or endoscopic brINS-0362onchoscopy are currently used for visualizing Model: INS-5450
| Date | Jul 28, 2023 (initiated May 15, 2023) |
| Status | Open, Classified |
| Reason | Electromagnetic (EM) sensor tracking malfunction impacts the use of navigation functionality during endobronchial procedures and prompts the system to report a coil break warning message. This could result in a potential procedural delay |
| Root cause | Component design/selection |
| Action | Olympus issued "URGENT - Medical Device Field Corrective Action" on 5/15/23. Letter states reason for recall, health risk and action to take: Olympus implemented a new internal component and has observed a reduction in complaints for the above-mentioned issue. However, to minimize the duration of potential procedure delay, Olympus is revising the Instruction for Use to add the below precaution statement: It is required to have additional Always-On Tip Tracked instruments available for all procedures as tracking may be lost when: Connecting the instrument to the SPiN Thoracic Navigation Syste |
| Quantity | 144 units |
| Distribution | Worldwide Distribution: US (Nationwide) and OUS (foreign) to countries of: CN, DE, HK, IT, KR, SG, TH & TW. |
| FDA record | Open on fda.gov |