Olympus Corporation of the Americas Recall 92383
Description: Always-On Tip Tracked Instruments (SPiN Drive instruments) Triple Needle Brush, 12mm L, 1.8mm OD-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-5300
Olympus Corporation of the Americas Recall 92383 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2267-2023 |
| Event ID | 92383 |
| Event Description | Always-On Tip Tracked Instruments (SPiN Drive instruments) Triple Needle Brush, 12mm L, 1.8mm OD-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-5300 |
| Product Type | Devices |
| Distribution | Worldwide Distribution: US (Nationwide) and OUS (foreign) to countries of: CN, DE, HK, IT, KR, SG, TH & TW. |
| Quantity | 759.8 units |
| Recall 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 |
| Device Classification | 20230809 |
| Device Code Info | UDI-DI:00815686021207 Lot Number: 04617200805 and below |
| Center Classification Date | 20230728 |
| Recall Initiation Date | 20230515 |
| Recalling Firm | Olympus Corporation of the Americas |
| Initial Notification | Letter |
| Similar To |