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

FDA device recall Z-1103-2023 · posted 2023-02-07 · Open, Classified

Recall details

Recalling firm

Olympus Corporation of the Americas

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

Action taken

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.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

JAK

Quantity affected

13 units

Distribution

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

Date initiated

2022-12-13

Date posted

2023-02-07

Location

Center Valley, PA

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