—#202826

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)

FDA product code: JAK — System, X-Ray, Tomography, Computed
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K093146, K122106, K170023
Affected lot / code info: 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

Why it was recalled

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 (FDA determination)

Under Investigation by firm

Action the firm took

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 Tara.Safi@Olympus.com.

Recalling firm

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

Distribution

Distribution pattern: Worldwide distribution - US Nationwide and the countries of CN, DE, HK, IT, KR, SG, TH, TW.

Timeline

Recall initiated: 2023-08-10
Posted by FDA: 2023-09-29
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #202826. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.