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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-2659-2023
Recall Event ID 92893
510(K)Number K170023  K093146  K122106  
Product Classification System, x-ray, tomography, computed - Product Code JAK
Product Veran:SPiN Thoracic Navigation System
Models:
SYS-4230 SPiN Thoracic Navigation System - 230V 50Hz
SYS-4000 SPiN Thoracic Navigation System
SYS-3230 ig4 System, 230V, 50Hz / SPiN Thoracic Navigation System 0095
SYS-3000 SPiN Thoracic Navigation System
SYS-2400 SPiN Drive System
SYS-2230 ig4 System V2, 230V, 50Hz
SYS-2000 ig4 Image Guides System
SYS-1500 SPiN View" System
SYS-1000 ig4 Image Guides System
SYS-0220 ig4 System, 220V, 50Hz
SYS-0185 SPiN Planning Laptop Workstation
SYS-0128 Planning Workstation w/Monitor
SYS-0002 ig4 System
INS-7150 SPiN Vision Scope Adapter
Code Information Model-UDI: SYS-4230 SPiN Thoracic Navigation System - 230V 50Hz 00815686020118; SYS-4000 SPiN Thoracic Navigation System 00815686020101; SYS-3230 ig4 System, 230V, 50Hz / SPiN Thoracic Navigation System 00815686020095; SYS-3000 SPiN Thoracic Navigation System 00815686020088; SYS-2400 SPiN Drive System N/A; SYS-2230 ig4 System V2, 230V, 50Hz 00815686020071; SYS-2000 ig4 Image Guides System 00815686020064; SYS-1500 SPiN View" System 00815686020057; SYS-1000 ig4 Image Guides System N/A; SYS-0220 ig4 System, 220V, 50Hz N/A; SYS-0185 SPiN Planning Laptop Workstation 00815686020033; SYS-0128 Planning Workstation w/Monitor N/A; SYS-0002 ig4 System N/A; INS-7150 SPiN Vision Scope Adapter N/A; 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 226 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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