FDA Device recall Z-2263-2014

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

FDA Device
Class II
terminated
Published 2014-08-27

On 2014-08-27 the FDA classified a Class II recall of WaterLase iPlus Dental Laser System, Part No. 7200854-XX Software Upgrade Kit, Part No. 6201463 by Biolase Technology, citing 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 scr….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-2263-2014
Classification	Class II
Status	terminated
Initiated	2014-06-12
Published	2014-08-27
Last updated	2026-09-13 11:53 UTC
Company	Biolase Technology
Distribution	US

Product

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

Reason

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.

Identifiers

code_info	Serial No. 72110047 72111060 72110077 72110128 72110263 72110281 72110286 72110343 72110469 72110836 72110… 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 721401

code_info

Serial No. 72110047 72111060 72110077 72110128 72110263 72110281 72110286 72110343 72110469 72110836 72110…

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 721401

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2263-2014%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.