| Class 2 Device Recall IG 4 Image Guided System | |
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
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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.
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Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = JAK
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