Recall Z-1206-2024 ยท FDF Colonoscope And Accessories, Flexible/Rigid
Olympus Corporation of the Americas
Colonoscope, Model Number CF-HQ190I.
| Date | Feb 29, 2024 (initiated Jan 11, 2024) |
| Status | Open, Classified |
| Reason | Specific repaired colonovideoscopes were assembled without an adhesive which protects them from certain physical conditions such as high levels of vibration, fluctuation in temperature or severe shock loads. |
| Root cause | Nonconforming Material/Component |
| Action | On January 11, 2024, the firm notified customers of the issue via URGENT MEDICAL DEVICE REMOVAL letters. Customers were instructed to inspect your inventory and identify any products of the model and lots subject to this action. Please check all areas of the hospital to determine if any of these devices remain in inventory. Quarantine and stop using the device. Customers were given detailed instructions on how to identify affected product. Our Olympus Customer Solutions team will contact you to arrange a no-charge return, and a loaner as necessary. Olympus will perform an inspection of your de |
| Quantity | 1 |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K112680 | EVIS EXERA III VIDEO SYSTEM Olympus Medical Systems Corporation, Feb 16, 2012 |