Z-1103-2023Class II

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

Name: Z-1103-2023 SPiN Thoracic Navigation System Model: SYS-4000 (SYS-4000D)
Creator: Olympus Corporation of the Americas
Published: 2022-12-13
License: https://open.fda.gov/license/

OLYMPUS Corporation of the Americas / initiated 2022-12-13 / Open, Classified

FDA source

Olympus Corporation of the Americas began a recall of SPiN Thoracic Navigation System Model: SYS-4000 (SYS-4000D) on 2022-12-13. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1103-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-12-13
Posted: 2023-02-07
Recalling firm: OLYMPUS Corporation of the Americas
Product: SPiN Thoracic Navigation System Model: SYS-4000 (SYS-4000D)
Product code: JAK System, X-Ray, Tomography, Computed
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 root cause: Under Investigation by firm
Action: 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 [email protected] for any additional information or support.
Quantity in commerce: 13 units
Distribution: FL, GA, IN, MD, MS, NY, OH, PA, RI, SC, VA
Product codes and lots: UDI: 00815686020101 Serial Numbers: 85330200430, 87896220519, 87899220524, 87379210921, 87835220505, 87832220502, 87767220420, 87777220415, 87827220427, 87736220412, 87891220517, 87864220509, 87738220412

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1103-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1103-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-02-15	2023-02-07

Product code JAK

K170023Class IISPiN Thoracic Navigation SystemVeran Medical Technologies, Inc. / cleared 2017-05-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)