—#197391

Product

SPiN Thoracic Navigation System Model: SYS-4000 (SYS-4000D)

FDA product code: JAK — System, X-Ray, Tomography, Computed
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K170023
Affected lot / code info: UDI: 00815686020101 Serial Numbers: 85330200430, 87896220519, 87899220524, 87379210921, 87835220505, 87832220502, 87767220420, 87777220415, 87827220427, 87736220412, 87891220517, 87864220509, 87738220412

Why it was 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

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

Olympus 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.

Recalling firm

Firm: Olympus Corporation of the Americas
Address: 3500 Corporate Pkwy, Center Valley, Pennsylvania 18034-8229

Distribution

Distribution pattern: FL, GA, IN, MD, MS, NY, OH, PA, RI, SC, VA

Timeline

Recall initiated: 2022-12-13
Posted by FDA: 2023-02-07
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #197391. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.