Reported Oct 11, 2023 · Ongoing
Veran : Percutaneous Always on Track Models: INS-5040 Always-On vTrack Universal Tracker, LG 7-12ga INS-5039 Always-On…
Olympus Corporation of the Americas
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Olympus Corporation of the Americas · 3500 Corporate Pkwy · Center Valley, PA · 18034-8229
Is this the product you have?
- VeranPercutaneous
- Always on Track ModelsINS-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, Chiba point" INS-5029 "19 UTW 105 mm Always-On Tip Tracked biopsy needle, Chiba oint" INS-5028 19 UTW 155 mm Always-On Tip Tracked biopsy needle, Chiba point INS-5024 "17ga 150mm Always-On Tip Tracked Biopsy Needle, Chiba point" INS-5023 17ga 100mm Always-On Tip Tracked Biopsy Needle, Chiba point INS-5017 17ga x 155mm Tip Tracked Bx Needle INS-5016 17ga x 155mm Tip Tracked Bx Needle
- Lot codes and dates
12 of 12 products
Products covered by this recall # Barcodes Product as published 1 00815686020705INS-5040 Always-On vTrack Universal Tracker, LG 7-12ga 00815686020705 2 00815686020699INS-5039 Always-On vTrack Universal Tracker, SM/CL, 12-18ga 00815686020699 3 00815686020361INS-5036 "22 UTW 125mm Always-On Tip Tracked Biopsy Needle, Trocar point" 00815686020361 4 00815686020354INS-5034 17 UTW Lg 123mm Always-On Tip Tracked Biopsy Needle, Chiba point 00815686020354 5 00815686020330INS-5032 "19 UTW 150mm Always-On Tip Tracked Biopsy Needle, Chiba point" 00815686020330 6 00815686020309INS-5029 "19 UTW 105 mm Always-On Tip Tracked biopsy needle, Chiba point" 00815686020309 7 00815686020293INS-5028 19 UTW 155 mm Always-On Tip Tracked biopsy needle, Chiba point 00815686020293 8 00815686020255INS-5024 "17ga 150mm Always-On Tip Tracked Biopsy Needle, Chiba point" 00815686020255 9 00815686020248INS-5023 17ga 100mm Always-On Tip Tracked Biopsy Needle, Chiba point 00815686020248 10 00815686020224INS-5017 17ga x 155mm Tip Tracked Bx Needle 00815686020224 11 00815686020217INS-5016 17ga x 155mm Tip Tracked Bx Needle 00815686020217 12 All serial numbers and all lot numbers - Amount recalled
- 522 units
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Where it was sold
- Nationwide
- DE
Why it was recalled
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
This product could cause temporary or reversible health problems — stop using it.
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