Veran : Endobronchial Always on Track Models: INS-0392 AOTT 21ga Needle, 12mm L, 1.8mm OD, 5/BX INS-0382 AOTT 19ga Needle, 12mm L, 1.8 OD, 5/Bx INS-0372 AOTT Serrated Forceps, 1.8mm OD, 5/Bx INS-0362 AOTT Oval Cup Forceps, 1.8mm OD, 5/Bx INS-0352 "Always-On Tip Tracked (AOTT) Brush, 15mm L, 1.8mm OD, 5/Bx" INS-0322 View Peripheral Catheter, 3.2mm OD, 2.0mm WC INS-0305 Always-On Tip Tracked Guidewire, 1.0mm, 950mm INS-0304 Always-On Tip Tracked Guidewire, 1.0mm, 735mm INS-0050 vPad Patient Tracker, 5/Bx INS-0048 vPad Connector Cable
This recall is currently active, issued September 29, 2023. It was issued by Olympus Corporation Of The Americas.
- Recall Initiated
- August 10, 2023
- Posted
- September 29, 2023
- Recall Number
- Z-2664-2023
- Quantity
- 60102 units
- Firm Location
- Center Valley, PA
- Official Source
- View on FDA website ↗
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
Distribution
Worldwide distribution - US Nationwide and the countries of CN, DE, HK, IT, KR, SG, TH, TW.
Lot / Code Info
INS-0392 AOTT 21ga Needle, 12mm L, 1.8mm OD, 5/BX 00815686020613; INS-0382 AOTT 19ga Needle, 12mm L, 1.8 OD, 5/Bx 00815686020590; INS-0372 AOTT Serrated Forceps, 1.8mm OD, 5/Bx 00815686020576; INS-0362 AOTT Oval Cup Forceps, 1.8mm OD, 5/Bx 00815686020538; INS-0352 "Always-On Tip Tracked (AOTT) Brush, 15mm L, 1.8mm OD, 5/Bx" 00815686020538; INS-0322 View Peripheral Catheter, 3.2mm OD, 2.0mm WC 00815686020477; INS-0305 Always-On Tip Tracked Guidewire, 1.0mm, 950mm 00815686020446; INS-0304 Always-On Tip Tracked Guidewire, 1.0mm, 735mm 00815686020439; INS-0050 vPad Patient Tracker, 5/Bx 00815686020408; INS-0048 vPad Connector Cable 00815686020392; All serial numbers and all lot numbers
Root Cause
Under Investigation by firm
Action Taken
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.