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Veran : Percutaneous Always on Track recallZ-2663-2023 · Olympus Corporation of the Americas · initiated Aug 10, 2023

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Olympus Corporation of the Americas or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

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

FDA root cause category: Under Investigation by firm

What the company is doing

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].

Recall details

Recall number
Z-2663-2023
Status
Open, Classified
Initiated by the company
Aug 10, 2023
Posted by the FDA
Sep 29, 2023
Recalling firm
Olympus Corporation of the Americas
Quantity
522 units
Product code
JAK
FDA submissions
K093146, K122106, K170023
Distribution
Worldwide distribution - US Nationwide and the countries of CN, DE, HK, IT, KR, SG, TH, TW.

Product description

Veran : Percutaneous Always on Track Models: INS-5040 Always-On vTrack Universal Tracker, LG 7-12ga INS-5039 Always-On vTrack Universal Tracker, SM/CL, 12-18ga INS-5036 "22 UTW 125mm Always-On Tip Tracked Biopsy Needle, Trocar point" INS-5034 17 UTW Lg 123mm Always-On Tip Tracked Biopsy Needle, Chiba point 00815686020354 INS-5032 "19 UTW 150mm Always-On Tip Tracked Biopsy Needle, Chiba point" INS-5029 "19 UTW 105 mm Always-On Tip Tracked biopsy needle, Chiba oint" INS-5028 19 UTW 155 mm Always-On Tip Tracked biopsy needle, Chiba point INS-5024 "17ga 150mm Always-On Tip Tracked Biopsy Needle, Chiba point" INS-5023 17ga 100mm Always-On Tip Tracked Biopsy Needle, Chiba point INS-5017 17ga x 155mm Tip Tracked Bx Needle INS-5016 17ga x 155mm Tip Tracked Bx Needle

Code information (models, lots, serial numbers)

Show the full code information (1k characters)

Model-UDI: INS-5040 Always-On vTrack Universal Tracker, LG 7-12ga 00815686020705; INS-5039 Always-On vTrack Universal Tracker, SM/CL, 12-18ga 00815686020699; INS-5036 "22 UTW 125mm Always-On Tip Tracked Biopsy Needle, Trocar point" 00815686020361; INS-5034 17 UTW Lg 123mm Always-On Tip Tracked Biopsy Needle, Chiba point 00815686020354; INS-5032 "19 UTW 150mm Always-On Tip Tracked Biopsy Needle, Chiba point" 00815686020330; INS-5029 "19 UTW 105 mm Always-On Tip Tracked biopsy needle, Chiba point" 00815686020309; INS-5028 19 UTW 155 mm Always-On Tip Tracked biopsy needle, Chiba point 00815686020293; INS-5024 "17ga 150mm Always-On Tip Tracked Biopsy Needle, Chiba point" 00815686020255; INS-5023 17ga 100mm Always-On Tip Tracked Biopsy Needle, Chiba point 00815686020248; INS-5017 17ga x 155mm Tip Tracked Bx Needle 00815686020224; INS-5016 17ga x 155mm Tip Tracked Bx Needle 00815686020217; All serial numbers and all lot numbers

Devices named in this recall

11 devices in the FDA device registry whose identifier appears in the recall's code information.

Other devices under the same FDA submission

30 devices cleared under K093146, K122106, K170023 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 92893).

Sources and updates

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