Recall Z-2263-2014 ยท GEX Powered Laser Surgical Instrument
Biolase Technology Inc
WaterLase iPlus Dental Laser System, Part No. 7200854-XX Software Upgrade Kit, Part No. 6201463.
| Date | Aug 18, 2014 (initiated Jun 12, 2014) |
| Status | Terminated |
| Reason | Biolase is recalling the WaterLase iPlus Dental Laser System because of a discrepancy present in the user interface software (version 1.7). If an error occurs in the procedure screen, the air setting will change to 1% and OFF. |
| Root cause | Under Investigation by firm |
| Action | An Urgent Medical Device Correction letter dated 6/12/2014 was sent to all customers who purchased the WaterLase iPlus Dental Laser System. The letter informs the customers of the problems identified and the actions to be taken. Customers are informed that a Field Service Engineer can install the software update. Customers with are instructed to contact Customer Service at (800) 321-6717. |
| Quantity | 117 units |
| Distribution | Nationwide in US and worldwide to: Canada, UK, Russia, Korea, Hong Kong, Libya, Iran, Iraq, Kuwait, Singapore, Armenia, Egypt, Pakistan, Sweden, New Zealand, Poland, Germany, Italy, UAE. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K101658 | WATERLASE MD TURBO PLUS MODEL 7200XXX Biolase Technology, Inc., Aug 11, 2010 |