Quick summary
Quick summary: Solea. Date: 2023-09-20.
Public recall detail
Solea
2023-09-20
Recall
Safety notice
Recommended action
Recommended action: compare your product with the official notice and follow the instructions published by the official source.
Recall details
Quick summary: Solea. Date: 2023-09-20.
Official details
Affected product details
Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.
BrandConvergent Dental, Inc.
ProductSolea
IssueMedical devices - Performance
Recall classType II
IdentificationRA-74308
Affected products
ProductSolea
LotSerial number 0310523
ModelMODEL 3.0
Serial numberSerial number 0310523
DescriptionSolea
Issue
In normal use, the laser is activated when the user sets the device to the "armed" state and when the foot pedal is depressed in the "armed" state. (the laser is deactivated when it is not in the armed state). However, there were reported events where the laser was activated in the armed state when the user did not actively depress the foot pedal. Recall start date: August 24, 2023
What you should do
- Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - Dental
CompaniesConvergent Dental, Inc. 140 Kendrick St., Needham, Massachusetts, United States, 02494
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-74308
Background{}
CompaniesConvergent Dental, Inc. 140 Kendrick St., Needham, Massachusetts, United States, 02494
AudiencesHealthcare
Source updated2023-09-20
Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.
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