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U.S. Department of Health and Human Services

Class 2 Device Recall IG 4 Image Guided System

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  Class 2 Device Recall IG 4 Image Guided System see related information
Date Initiated by Firm August 10, 2023
Date Posted September 29, 2023
Recall Status1 Open3, Classified
Recall Number Z-2663-2023
Recall Event ID 92893
510(K)Number K093146  K122106  K170023  
Product Classification System, x-ray, tomography, computed - Product Code JAK
Product 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
Code Information 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
Recalling Firm/
Manufacturer		 Olympus Corporation of the Americas
3500 Corporate Pkwy
Center Valley PA 18034-8229
For Additional Information Contact SAME
484-896-5000
Manufacturer 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
FDA Determined
Cause 2		 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 any of these devices remain in inventory. 2. Call your Olympus customer service representative at 1-800-848-9024, option 2. Olympus will issue a Return Material Authorization to return any affected product at no charge. Your Olympus Customer Service representative will advise you on reimbursement for your Veran devices. 3. Olympus requests that you acknowledge receipt of this letter through the Olympus recall portal. a. Go to https://olympusamerica.com/recall b. Enter the file (recall) number: 0430 4. If you have further distributed this product, identify your customers, forward them this notification, and appropriately document your notification process. If you require additional information, please contact Tara Safi, Field Corrective Actions Administrator at Tara.Safi@Olympus.com.
Quantity in Commerce 522 units
Distribution Worldwide distribution - US Nationwide and the countries of CN, DE, HK, IT, KR, SG, TH, TW.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = JAK and Original Applicant = VERAN MEDICAL TECHNOLOGIES, INC.
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