Olympus CHF-CB30S Choledoscope Intended Use: The device recall
Olympus CHF-CB30S Choledoscope Intended Use: The device was designed to be used with an Olympus TV camera system, light source, TV monitor…
Why was Olympus CHF-CB30S Choledoscope Intended Use: The device recalled?
The CHF-CB30S Device did not have a 510(k) clearance. Additionally, the device has been associated with breakage of the insertion section and protrusion of metal parts, as well as breakage and displacement of the rubber on the bending section during surgical procedures.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
All lot codes..
- Product
- Olympus CHF-CB30S Choledoscope Intended Use: The device was designed to be used with an Olympus TV camera system, light source, TV monitor…
- Recalling firm
- Olympus Corporation of the Americas
- Quantity
- 193 devices distributed in the U.S. 548 devices distributed globally.
- Distribution
- US Nationwide Distribution in states of: AK, AZ, CA, FL, GA, IL, LA, MA, ME, MI, MN, MS, NC, NM, NJ, NY, OR, SC, TN, WA, and WI; and International to: Japan.
- Recall date
- October 28, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)