Olympus Single Use Mechanical Lithotriptor, Model Number BML-V232QR-26, Olympus America, Inc.
FDA device recall Z-0105-2008 · posted 2007-10-31 · Terminated
Recall details
- Recalling firm
- Olympus America Inc.
- Reason for recall
- Slider knob does not move smoothly causing the user difficulty in advancing the coil sheath
- Action taken
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- LQC
- Quantity affected
- 91 units
- Distribution
- Nationwide
- Date initiated
- 2007-09-20
- Date posted
- 2007-10-31
- Date terminated
- 2008-02-15
- Location
- Center Valley, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BML SERIES (K903529) | Olympus Corp. | 1991-01-23 |