Z-2661-2023Class II

Veran : Percutaneous Models: INS-5620 SPiN Perc Biopsy Needle Guide Kit - 20cm, 5/Bx (includes INS-5028)"...

Name: Z-2661-2023 Veran : Percutaneous Models: INS-5620 SPiN Perc Biopsy Needle Guide Kit - 20cm, 5/Bx (includes INS-5028)"...
Creator: Olympus Corporation of the Americas
Published: 2023-08-10
License: https://open.fda.gov/license/

OLYMPUS Corporation of the Americas / initiated 2023-08-10 / Open, Classified / root cause: manufacturing process

FDA source

Olympus Corporation of the Americas began a recall of Veran : Percutaneous Models: INS-5620 SPiN Perc Biopsy Needle Guide Kit - 20cm, 5/Bx (includes INS-5028)" INS-5611 SPiN Perc Localization Needle - 2cm, 5/Bx... on 2023-08-10. FDA classified it as Class II and gives the reason as "Non-conformances in Veran devices (ig4 Image Guided System, SPiN Thoracic Navigation System, SPiN Planning Laptop Workstation, and all associated navigation instruments) manufacturing to design requirements and...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2661-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-08-10
Posted: 2023-09-29
Recalling firm: OLYMPUS Corporation of the Americas
Product: Veran : Percutaneous Models: INS-5620 SPiN Perc Biopsy Needle Guide Kit - 20cm, 5/Bx (includes INS-5028)" INS-5611 SPiN Perc Localization Needle - 2cm, 5/Bx INS-5610 SPiN Perc Localization Needle - 1cm, 5/Bx INS-5600 SPiN Perc Biopsy Needle Guide Kit, 5/Bx (includes INS-5029)
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: Non-conformances in Veran devices (ig4 Image Guided System, SPiN Thoracic Navigation System, SPiN Planning Laptop Workstation, and all associated navigation instruments) manufacturing to design requirements and insufficient evidence to demonstrate adequate electromagnetic compatibility (EMC). EMC is the ability of electrical equipment and systems to function acceptably without interference and to not interfere with other devices within its operating environment
Root cause tag: manufacturing process
FDA root cause: Under Investigation by firm
Action: Olympus Corporation of the Americas ( Olympus ),[Veran Medical Technologies, a wholly owned subsidiary] issued Urgent Medical Device Recall Letter on 8/10/23 to: Endoscopy Department, Pulmonary Department, Risk Management for the VERAN ig4 Image Guided System, SPiN Thoracic Navigation System, SPiN Planning Laptop Workstation, and all associated navigation instruments. Letter states reason for recall, health risk and action to take: Veran requests you to take the following actions: 1. Inspect your inventory and identify any Veran models. Please check all areas of the hospital to determine if any of these devices remain in inventory. 2. Call your Olympus customer service representative at 1-800-848-9024, option 2. Olympus will issue a Return Material Authorization to return any affected product at no charge. Your Olympus Customer Service representative will advise you on reimbursement for your Veran devices. 3. Olympus requests that you acknowledge receipt of this letter through the Olympus recall portal. a. Go to https://olympusamerica.com/recall b. Enter the file (recall) number: 0430 4. If you have further distributed this product, identify your customers, forward them this notification, and appropriately document your notification process. If you require additional information, please contact Tara Safi, Field Corrective Actions Administrator at [email protected].
Quantity in commerce: 9961 units
Distribution: Worldwide distribution - US Nationwide and the countries of CN, DE, HK, IT, KR, SG, TH, TW.
Product codes and lots: Model-UDI: INS-5620 SPiN Perc Biopsy Needle Guide Kit - 20cm, 5/Bx (includes INS-5028)" 00815686021122; INS-5611 SPiN Perc¿ Localization Needle - 2cm, 5/Bx 00815686021146; INS-5610 SPiN Perc¿ Localization Needle - 1cm, 5/Bx 00815686021139; INS-5600 SPiN Perc¿ Biopsy Needle Guide Kit, 5/Bx (includes INS-5029) 00815686020736. All serial numbers and all lot numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2661-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2659-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-10-11	2023-09-29
Z-2660-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-10-11	2023-09-29
Z-2661-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-10-11	2023-09-29
Z-2662-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-10-11	2023-09-29
Z-2663-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-10-11	2023-09-29
Z-2664-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-10-11	2023-09-29

Product code JAK

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)