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U.S. Department of Health and Human Services

Class 2 Device Recall SPiN Thoracic Navigation System

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 Class 2 Device Recall SPiN Thoracic Navigation Systemsee related information
Date Initiated by FirmDecember 13, 2022
Date PostedFebruary 07, 2023
Recall Status1 Open3, Classified
Recall NumberZ-1103-2023
Recall Event ID 91291
510(K)NumberK170023 
Product Classification System, x-ray, tomography, computed - Product Code JAK
ProductSPiN Thoracic Navigation System Model: SYS-4000 (SYS-4000D)
Code Information UDI: 00815686020101 Serial Numbers: 85330200430, 87896220519, 87899220524, 87379210921, 87835220505, 87832220502, 87767220420, 87777220415, 87827220427, 87736220412, 87891220517, 87864220509, 87738220412
FEI Number 2429304
Recalling Firm/
Manufacturer		 Olympus Corporation of the Americas
3500 Corporate Pkwy
Center Valley PA 18034-8229
For Additional Information ContactSAME
484-896-5000
Manufacturer Reason
for Recall		A grainy image is observed when using a SPiN Vision Single-Use Flexible Bronchoscope (models INS-7100 or INS-7130) with the SYS-4000 system due to an incorrect DVI cable supplied may result in prolonged procedure/surgery due to additional time to troubleshoot the device
FDA Determined
Cause 2		Under Investigation by firm
ActionOlympus issued URGENT - Medical Device Field Corrective Action letter on 12/13/22. Letter states reason for recall, health risk and action to take: 1. Notify your users about this issue and stop using the single-use bronchoscopes (models INS-7100 or INS-7130) with SYS-4000 system until cable is replaced. Your users can continue to use the SYS-4000 using a reusable bronchoscope, with its respective video processor, without affecting their electromagnetic navigation (EMN) procedural experience. 2. Olympus requests that you acknowledge receipt of this letter by accessing the Olympus recall portal. Go to https://olympusamerica.com/recall. Enter the recall number 0418 Provide your contact information as indicated in the portal. An Olympus Field Service Representative will contact you to schedule a site visit to replace the DVI cable. 3. If you have distributed these devices outside your facility, please notify your customers of this matter immediately. Your notification to your customers may be enhanced by including a copy of this letter. Olympus requests that you report complaints, including patient injuries and adverse events, to Olympus. Please report complaints to our Technical Assistance Center (TAC) at 1-800-848-9024, option 1 to report complaints. Contact (647) 999-3203 or at Cynthia.Ow@Olympus.com for any additional information or support.
Quantity in Commerce13 units
DistributionFL, GA, IN, MD, MS, NY, OH, PA, RI, SC, VA
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = JAK
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