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Terminated

WaterLase iPlus Dental Laser System, Part No. 7200854-XX Software Upgrade Kit, Part No. 6201463.

FDA Recall Z-2263-2014 · Posted 2014-08-18

Recalling FirmBiolase Technology Inc
Recall StatusTerminated
Product CodeGEX
Date Initiated2014-06-12
Date Terminated2014-10-06
Product Quantity117 units

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.

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.

Root Cause

Under Investigation by firm

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K101658WATERLASE MD TURBO PLUS MODEL 7200XXXBiolase Technology, Inc. · 2010-08-11

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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