Recall Z-0543-05 ยท LYB
Biolase Technology Inc
Waterlase MD, dental laser unit, Model #6200218, serial numbers 10500210 to 105202680, inclusive.
| Date | Feb 15, 2005 (initiated Jan 17, 2005) |
| Status | Terminated |
| Reason | Reports that the Waterlase MD, a dental laser unit, water bottle broke under pressure during installation. |
| Root cause | Other |
| Action | 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. |
| Quantity | 206 units |
| Distribution | Nationwide, Canada, Germany, Ireland, France, United Arab Emirates, Lebanon, Greece, Hong Kong, Argentina, Indonesia, Estonia, Spain, Taiwan |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K031140 | WATERLASE Biolase Technology, Inc., Jul 7, 2004 |