Recall Z-2663-2023 ยท JAK System, X-Ray, Tomography, Computed
Olympus Corporation of the Americas
Veran : Percutaneous Always on Track Models: INS-5040 Always-On vTrack Universal Tracker, LG 7-12ga INS-5039 Always-On vTrack Universal Tracker, SM/CL, 12-18ga INS-5036 "22 UTW 125mm Always-On Tip Tracked Biopsy Needle, Trocar point" INS-5034 17 UTW Lg 123mm Always-On Tip Tracked Biopsy Needle, Chiba point 00815686020354 INS-5032 "19 UTW 150mm Always-On Tip Tracked Biopsy Needle
| 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 | 522 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
| K093146 | IG4 IMAGE GUIDED SYSTEM, MODEL: SYS-0200 Veran Medical Technologies, Inc., Nov 30, 2009 |
| K122106 | SPIN DRIVE ALWAYS-ON TIP TRACKED STEERABLE CATHETER ALWAYS-ON TIP TRACKED SHEATH ALWAYS-ON TIP TRACKED ASPIRATION NEEDLE Veran Medical Technologies, Inc., Dec 21, 2012 |
| K170023 | SPiN Thoracic Navigation System Veran Medical Technologies, Inc., May 15, 2017 |