Waterlase MD, dental laser unit, Model #6200218, serial numbers 10500210 to 105202680, inclusive.
FDA device recall Z-0543-05 · posted 2005-02-15 · Terminated
Recall details
- Recalling firm
- Biolase Technology Inc
- Reason for recall
- Reports that the Waterlase MD, a dental laser unit, water bottle broke under pressure during installation.
- Action taken
- Water bottles will be replaced by trained Biolase representatives. During that visit, the representative will verify that the bottle pressure is set correctly and the existing bottle is replaced with a new bottle.
- Root cause
- Other
- Status
- Terminated
- Product code
- LYB
- Quantity affected
- 206 units
- Distribution
- Nationwide, Canada, Germany, Ireland, France, United Arab Emirates, Lebanon, Greece, Hong Kong, Argentina, Indonesia, Estonia, Spain, Taiwan
- Date initiated
- 2005-01-17
- Date posted
- 2005-02-15
- Date terminated
- 2005-08-17
- Location
- San Clemente, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| WATERLASE (K031140) | Biolase Technology, Inc. | 2004-07-07 |