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Terminated

Waterlase MD, dental laser unit, Model #6200218, serial numbers 10500210 to 105202680, inclusive.

FDA Recall Z-0543-05 · Posted 2005-02-15

Recalling FirmBiolase Technology Inc
Recall StatusTerminated
Product CodeLYB
Date Initiated2005-01-17
Date Terminated2005-08-17
Product Quantity206 units

Reason for Recall

Reports that the Waterlase MD, a dental laser unit, water bottle broke under pressure during installation.

Firm 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.

Root Cause

Other

Distribution Pattern

Nationwide, Canada, Germany, Ireland, France, United Arab Emirates, Lebanon, Greece, Hong Kong, Argentina, Indonesia, Estonia, Spain, Taiwan

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K031140WATERLASEBiolase Technology, Inc. · 2004-07-07

Official Source

View FDA Recall →

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

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