Veran : Percutaneous Always on Track Models: INS-5040 Always-On vTrack Universal Tracker, LG 7-12ga INS-5039 Alw
Summary
The FDA issued a Class II for Veran : Percutaneous Always on Track Models: INS-5040 Always-On vTrack Univers by Olympus Corporation of the Americas. Reason: Non-conformances in Veran devices (ig4 Image Guided System, SPiN Thoracic Navigation System, SPiN Planning Laptop Workstation, and all associated navi.
Details
Source
Device Recall
External ID
Z-2663-2023
Action Date
2023-10-11
Status
Ongoing
Category
device
Product Description
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, 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/Code Info: Model-UDI: INS-5040 Always-On vTrack Universal Tracker, LG 7-12ga 00815686020705; INS-5039 Always-On vTrack Universal Tracker, SM/CL, 12-18ga 00815686020699; INS-5036 "22 UTW 125mm Always-On Tip Tracked Biopsy Needle, Trocar point" 00815686020361; 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" 00815686020330; INS-5029 "19 UTW 105 mm Always-On Tip Tracked biopsy needle, Chiba point" 00815686020309; INS-5028 19 UTW 155 mm Always-On Tip Tracked biopsy needle, Chiba point 00815686020293; INS-5024 "17ga 150mm Always-On Tip Tracked Biopsy Needle, Chiba point" 00815686020255; INS-5023 17ga 100mm Always-On Tip Tracked Biopsy Needle, Chiba point 00815686020248; INS-5017 17ga x 155mm Tip Tracked Bx Needle 00815686020224; INS-5016 17ga x 155mm Tip Tracked Bx Needle 00815686020217; All serial numbers and all lot numbers
Quantity Affected: 522 units
Reason for Recall
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
Distribution
Worldwide distribution - US Nationwide and the countries of CN, DE, HK, IT, KR, SG, TH, TW.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-08-10
Company
Center Valley, PA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 142 device recalls issued in the same week, part of 413 device-related FDA actions this month.
Olympus Corporation of the Americas has 334 FDA actions in our database, including 334 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Olympus Corporation of the Americas) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Olympus Corporation of the Americas have FDA actions?
Olympus Corporation of the Americas has 334 FDA actions in our database, including 334 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2663-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
Want to know the moment something like this happens?
Get alerts for deviceRelated Actions
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, IC Tray REF: 888810200
Covidien LP · 2023-08-23
Sterile Procedural Trays, labeled as the following: a. BREAST AUGMENTATION b. BREAST REDUCTION CDS c. CUH ABDOMINO
MEDLINE INDUSTRIES, LP - Northfield · 2023-02-15
VTC Regular Kit Nephrostomy Catheter System Kit, Material Number REF M001245300; to provide external drainage of the uri
Boston Scientific Corporation · 2024-09-25
EnChroma Safety Glasses with Rx Indoor Universal Lenses: Martinez Cx1 Indoor Rx, SKU: Cx.PC.IN.MTZ.BK.Rx; Summit Indoo
Enchroma Inc · 2024-11-27
Otological Ventilation Tube - T-Tube 9mm - Silicone; Product Code: NZ3309;
Adept Medical Ltd · 2025-01-29