Z-0050-2014Class II

Solea 1.0 Laser Surgical instrument for use in general and plastic surgery and dermatology

Name: Z-0050-2014 Solea 1.0 Laser Surgical instrument for use in general and plastic surgery and dermatology
Creator: Convergent Dental
Published: 2013-09-12
License: https://open.fda.gov/license/

Convergent Dental / initiated 2013-09-12 / Terminated / root cause: software

FDA source

Convergent Dental began a recall of Solea 1.0 Laser Surgical instrument for use in general and plastic surgery and dermatology on 2013-09-12. FDA classified it as Class II and gives the reason as "Specific error condition could lead to unintended laser emission during laser activation". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0050-2014
Classification: Class II
Status: Terminated
Initiated: 2013-09-12
Posted: 2013-10-22
Terminated: 2013-11-15
Recalling firm: Convergent Dental
Product: Solea 1.0 Laser Surgical instrument for use in general and plastic surgery and dermatology.
Product code: GEX Powered Laser Surgical Instrument
Reason for recall: Specific error condition could lead to unintended laser emission during laser activation.
Root cause tag: software
FDA root cause: 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0050-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0050-2014	Class II	Terminated	Voluntary: Firm initiated	2013-10-30	2013-10-22

Product code GEX

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)