Recall Z-0107-2008 ยท LQC Lithotriptor, Biliary Mechanical
Olympus America Inc.
Olympus Single Use Mechanical Lithotriptor, Model number BML-V242QR-30, Olympus America, Inc.
| Date | Oct 31, 2007 (initiated Sep 20, 2007) |
| Status | Terminated |
| Reason | Slider knob does not move smoothly causing the user difficulty in advancing the coil sheath |
| Root cause | Process control |
| Action | The recalling firm issued a recall letter dated 9/20/07 to the medical facilities informing them of the problem and the need to return the product. The letter also informed the hospitals that replacement products would be sent. |
| Quantity | 153 units |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K903529 | BML SERIES Olympus Corp., Jan 23, 1991 |