WaterLase iPlus Dental Laser System, Part No. 7200854-XX Software Upgrade Kit, Part No. 6201463.
FDA device recall Z-2263-2014 · posted 2014-08-18 · Terminated
Recall details
- Recalling firm
- Biolase Technology Inc
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Under Investigation by firm
- Status
- Terminated
- Product code
- GEX
- Quantity affected
- 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.
- Date initiated
- 2014-06-12
- Date posted
- 2014-08-18
- Date terminated
- 2014-10-06
- Location
- Irvine, 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 MD TURBO PLUS MODEL 7200XXX (K101658) | Biolase Technology, Inc. | 2010-08-11 |