Recall Z-2660-2023 ยท JAK System, X-Ray, Tomography, Computed
Olympus Corporation of the Americas
Veran Endobronchial: Models: INS-5925 SPiN Access Catheter 180 Degree for use w/ Pentax Scopes INS-5920 SPiN Access Catheter 90 Degree for use w/ Pentax Scopes INS-5915 SPiN Access Catheter 180 for use w/ Olympus Scopes INS-5910 SPiN Access Catheter 90 for use w/ Olympus 190 Scopes INS-5905 SPiN Access Catheter 180 for use w/ Olympus Scopes INS-5900 SPiN Access Catheter 90 D
| Date | Sep 29, 2023 (initiated Aug 10, 2023) |
| Status | Open, Classified |
| Reason | Non-conformances in Veran devices (ig4 Image Guided System, SPiN Thoracic Navigation System, SPiN Planning Laptop Workstation, and all associated navigation instruments) manufacturing to design requirements and insufficient evidence to demonstrate adequate electromagnetic compatibility (EMC). EMC is the ability of electrical equipment and systems to function acceptably without interference and to not interfere with other devices within its operating environment |
| Root cause | Under Investigation by firm |
| Action | Olympus Corporation of the Americas ( Olympus ),[Veran Medical Technologies, a wholly owned subsidiary] issued Urgent Medical Device Recall Letter on 8/10/23 to: Endoscopy Department, Pulmonary Department, Risk Management for the VERAN ig4 Image Guided System, SPiN Thoracic Navigation System, SPiN Planning Laptop Workstation, and all associated navigation instruments. Letter states reason for recall, health risk and action to take: Veran requests you to take the following actions: 1. Inspect your inventory and identify any Veran models. Please check all areas of the hospital to determine if a |
| Quantity | 6484 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of CN, DE, HK, IT, KR, SG, TH, TW. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K170023 | SPiN Thoracic Navigation System Veran Medical Technologies, Inc., May 15, 2017 |