SPiN Thoracic Navigation System recall
SPiN Thoracic Navigation System Model: SYS-4000 (SYS-4000D)
Why was SPiN Thoracic Navigation System recalled?
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
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI: 00815686020101 Serial Numbers: 85330200430, 87896220519, 87899220524, 87379210921, 87835220505, 87832220502, 87767220420, 87777220415, 87827220427, 87736220412, 87891220517, 87864220509, 87738220412
- Product
- SPiN Thoracic Navigation System Model: SYS-4000 (SYS-4000D)
- Recalling firm
- Olympus Corporation of the Americas
- Quantity
- 13 units
- Distribution
- FL, GA, IN, MD, MS, NY, OH, PA, RI, SC, VA
- Recall date
- February 15, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)