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U.S. Department of Health and Human Services

Class 2 Device Recall Solea 1.0

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  Class 2 Device Recall Solea 1.0 see related information
Date Initiated by Firm September 12, 2013
Date Posted October 22, 2013
Recall Status1 Terminated 3 on November 15, 2013
Recall Number Z-0050-2014
Recall Event ID 66361
510(K)Number K123494  K130420  
Product Classification CO2 laser - Product Code GEX
Product Solea 1.0 Laser Surgical instrument for use in general and plastic surgery and dermatology.
Code Information Serial Numbers: CDS1-DVSU-1B-JU-13; CDS1-7QRE-1B-JU-13; CDS1-22TZ-1B-JU-13; CDS1-PNJZ-1B-AU-13; CDS1-A4CQ-1B-AU-13
Recalling Firm/
Manufacturer		 Convergent Dental
2 Vision Dr
Natick MA 01760-2086
Manufacturer Reason
for Recall		 Specific error condition could lead to unintended laser emission during laser activation.
FDA Determined
Cause 2		 Software design
Action The following Notice of Correction letter was sent out to all customers via email on 9/12/13, and followed up with a direct phone call to confirm receipt and review the contents of the letter: Dear Dr. [Customer name], This email is to inform you of a pending notice of correction regarding your Solea system, serial #[Customer serial number]. We have identified a specific error condition that could lead to unintended laser emission during laser activation. The software defect that caused the error condition has been identified and tested. Please do not use your Solea system until further notice. Resolution of this issue will require the installation of an updated release of the Solea software. A representative from Convergent Dental will be in touch with you to schedule the upgrade. Convergent Dental is committed to product quality and patient safety. If you have questions about this issue, please contact us. Software fix and testing: New software version (Release 2.0.4.0) was created by the software development group. Convergent Dental has implemented two software changes to eliminate this problem. The first is a defect fix to correct the handling of fatal errors, specifically laser communication timeout errors, so that these errors are not able to be cleared. This will prevent the user from being able to re-enter the workflow after a fatal error. The second is a defect fix to not set the laser state to disconnected when a laser timeout error condition occurs. This will ensure that the command to stop laser emission is always sent to the laser control module anytime the laser cutting state is exited due to error condition or the normal workflow event of stepping off the foot pedal. The software development team ran full Unit and Integration Tests on the new software build. The software verification activities included execution of the full verification test plan (Doc #790-00001), which has been revised to include specific defect
Quantity in Commerce 5
Distribution US distribution including states of: MA, CT, NY.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = GEX and Original Applicant = CONVERGENT DENTAL, INC
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