WaterLase iPlus Dental Laser System, Part No. 7200854-XX Software Upgrade Kit, Part No. 6201463.
FDA Device Recall #Z-2263-2014 — Class II — June 12, 2014
Recall Summary
| Recall Number | Z-2263-2014 |
| Classification | Class II — Moderate risk |
| Date Initiated | June 12, 2014 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Biolase Technology Inc |
| Location | Irvine, CA |
| Product Type | Devices |
| Quantity | 117 units |
Product Description
WaterLase iPlus Dental Laser System, Part No. 7200854-XX Software Upgrade Kit, Part No. 6201463.
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.
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.
Lot / Code Information
Serial No. 72110047 72111060 72110077 72110128 72110263 72110281 72110286 72110343 72110469 72110836 72110940 72110983 72130260 72130263 72140014 72140033 72140034 72140036 72140037 72140038 72140041 72140042 72140045 72140046 72140047 72140048 72140052 72140054 72140057 72140058 72140059 72140060 72140061 72140063 72140064 72140066 72140068 72140070 72140072 72140078 72140110 72140111 72140083 72140114 72140165 72140176 72140126 72140129 72140129 72140130 72140136 72140139 72140140 72140141 72140144 72140145 72140152 72140153 72120052 72140039 72140077 72140079 72140090 72140127 72140131 72140133 72140148 72140177 72140051 72140053 72140055 72140056 72140073 72140074 72140075 72140085 72140076 72140154 72120057 72130195 72130540 72130631 72140132 72140112 72140067 72140128 72140071 72140087 72140089 72140086 72140084 72140088 72140123 72140106 72140107 72140146 72140108 72140137 72140122 72140134 72140124 72140115 72140116 72140117 72140118 72140119 72140120 72140121 72140091 72140092 72140095 72140096 72140097 72140098 72140099 72140125
Frequently Asked Questions
A software recall means the device's embedded software or firmware has a defect that could affect its performance or safety. Many software recalls are corrected through firmware updates that can be applied without physically replacing the device. For implantable devices, the update may be delivered wirelessly during a routine clinic visit. For external devices, the manufacturer may provide updated software files or replacement units. Contact your healthcare provider to determine whether your specific device and software version are affected and what action is recommended.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.