Recall Z-2661-2023 ยท JAK System, X-Ray, Tomography, Computed
Olympus Corporation of the Americas
Veran : Percutaneous Models: INS-5620 SPiN Perc Biopsy Needle Guide Kit - 20cm, 5/Bx (includes INS-5028)" INS-5611 SPiN Perc Localization Needle - 2cm, 5/Bx INS-5610 SPiN Perc Localization Needle - 1cm, 5/Bx INS-5600 SPiN Perc Biopsy Needle Guide Kit, 5/Bx (includes INS-5029)
| 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 | 9961 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 |