Thoracic Navigation System Recalled for Incorrect Cable Causing Grainy Imaging
Olympus is recalling the SPiN Thoracic Navigation System (model SYS-4000) due to an incorrect DVI cable that produces grainy images during bronchoscopy procedures, requiring extended troubleshooting time.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a medical device with a functional defect (incorrect cable causing image quality issues) that could impair proper clinical use. The grainy imaging during a critical bronchoscopy procedure represents a risk-of-harm product where injury has not yet been reported, meeting the Score 3 (High) criterion.
Plain-English summary
Olympus Corporation of the Americas is recalling the SPiN Thoracic Navigation System, Model SYS-4000 (SYS-4000D), when used with the SPiN Vision Single-Use Flexible Bronchoscope (models INS-7100 and INS-7130).
The recall is caused by an incorrect DVI cable supplied with the navigation system. This cable produces grainy imaging during bronchoscopy procedures.
The defective imaging may result in prolonged procedure and surgery time while medical staff troubleshoots the device. Thirteen units have been distributed to medical facilities in Florida, Georgia, Indiana, Maryland, Mississippi, New York, Ohio, Pennsylvania, Rhode Island, South Carolina, and Virginia.
The recalled product
- Product
- SPiN Thoracic Navigation System Model: SYS-4000 (SYS-4000D)
- Manufacturer
- Olympus Corporation of the Americas
- Affected units
- 13
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (13)
- UDI: 00815686020101 Serial Numbers: 85330200430
- 87896220519
- 87899220524
- 87379210921
- 87835220505
- 87832220502
- 87767220420
- 87777220415
- 87827220427
- 87736220412
- 87891220517
- 87864220509
- 87738220412
Distribution
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