Reported Oct 11, 2023 · Ongoing
Veran : Endobronchial Models: INS-5500 View Optical Probe INS-5450 SPiN Xtend¿ 21ga, 1.8 OD, 5/Bx INS-5440 View…
Olympus Corporation of the Americas
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Olympus Corporation of the Americas · 3500 Corporate Pkwy · Center Valley, PA · 18034-8229
Is this the product you have?
- VeranEndobronchial
- ModelsINS-5500 View Optical Probe INS-5450 SPiN Xtend¿ 21ga, 1.8 OD, 5/Bx INS-5440 View Peripheral Catheter, 3.8mm OD, 2.5mm WC INS-5411 0.016" Stylet, 1235 mm L, 10/Bx INS-5410 SPiN Flex¿ ANSO¿ Needle, 22ga, 1.8mm OD, 5/Bx INS-5323 Sliding stopper INS-5300 "Always-On Tip Tracked¿ Triple Needle Brush, 12mm L, 1.8mm OD, 5/Bx"
- Lot codes and dates
7 of 7 products
Products covered by this recall # Barcodes Product as published 1 00815686020729INS-5500 View Optical Probe 00815686020729 2 00815686020651INS-5450 SPiN Xtend¿ 21ga, 1.8 OD, 5/Bx 00815686020651 3 00815686020644INS-5440 View Peripheral Catheter, 3.8mm OD, 2.5mm WC 00815686020644 4 00815686021191INS-5411 0.016" Stylet, 1235 mm L, 10/Bx 00815686021191 5 00815686020637INS-5410 SPiN Flex¿ ANSO¿ Needle, 22ga, 1.8mm OD, 5/Bx 00815686020637 6 00815686020712INS-5323 Sliding stopper 00815686020712 7 00815686021207INS-5300 "Always-On Tip Tracked¿ Triple Needle Brush, 12mm L, 1.8mm OD, 5/Bx" 00815686021207 . All serial numbers and all lot numbers - Amount recalled
- 6318 units
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Where it was sold
- Nationwide
- DE
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
This product could cause temporary or reversible health problems — stop using it.
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