Biolase Recalls WaterLase iPlus Dental Laser Systems Due to Software Error
Biolase Technology Inc is recalling 117 WaterLase iPlus Dental Laser Systems because a software error may cause the air setting to change to 1% and OFF during procedures.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any illnesses, injuries, or hospitalizations. The hazard is a software malfunction that alters device settings, which fits the criteria for a moderate severity recall involving a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Biolase Technology Inc is recalling 117 units of the WaterLase iPlus Dental Laser System (Part No. 7200854-XX) and the associated Software Upgrade Kit (Part No. 6201463). The recall is due to a discrepancy in the user interface software, version 1.7.
The specific issue involves the procedure screen. If an error occurs on this screen, the air setting will automatically change to 1% and OFF. The affected units were distributed nationwide in the US and worldwide to Canada, UK, Russia, Korea, Hong Kong, Libya, Iran, Iraq, Kuwait, Singapore, Armenia, Egypt, Pakistan, Sweden, New Zealand, Poland, Germany, Italy, and UAE.
Dental practices and consumers should check their device serial numbers against the list provided by the FDA to determine if their unit is affected. If a unit is affected, users should contact Biolase Technology Inc for further instructions on how to resolve the software discrepancy.
The recalled product
- Product
- WaterLase iPlus Dental Laser System, Part No. 7200854-XX Software Upgrade Kit, Part No. 6201463.
- Manufacturer
- Biolase Technology Inc
- Affected units
- 117
Distribution
Distributed nationwide across the United States.
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