Convergent Dental recalls Solea 2.0 and 3.0 laser surgical instruments with specific foot pedal assemblies due to potential unintended laser activation without foot pedal depression.
It has been found that potential unintended laser activation can occur without foot pedal depression.
Convergent Dental is recalling Solea Models 2.0 and 3.0 laser surgical instruments with certain foot pedal assemblies. This recall is because the foot pedal assembly could activate the laser without being depressed, which poses a risk of unintended laser exposure during surgery.
The foot pedal assembly can activate the laser without being pressed, meaning the laser might turn on unexpectedly during surgery. This could cause unintended exposure to the laser beam, potentially harming the patient or staff if not properly controlled.
Dental professionals using Solea Models 2.0 and 3.0 with the specific foot pedal assembly (SUB-00434 with foot pedal CUS-00226 Rev. K) are most at risk. Patients and staff in dental settings using these instruments could be exposed to unintended laser activation.
Check for the foot pedal assembly labeled SUB-00434 with foot pedal CUS-00226 Rev. K. Solea Model 3.0 units with serial numbers starting with 0310516-0310543 and 0310317, 0310321, 0310322, 0300730 are affected. Solea Model 2.0 units with serial numbers listed in the recall notice are also affected.
Verify if your Solea Model 2.0 or 3.0 has the foot pedal assembly SUB-00434 with foot pedal CUS-00226 Rev. K.
Reach out to Convergent Dental for guidance on whether your instrument is affected and next steps.
No, only Solea Models 2.0 and 3.0 with specific foot pedal assemblies (SUB-00434 with foot pedal CUS-00226 Rev. K) are affected.
Check with Convergent Dental to confirm if your instrument is affected and follow their instructions for next steps.
The recall states that the hazard could cause unintended activation, so it's recommended to check with Convergent Dental before continuing use.
We’ve drafted a message you can send Convergent Dental to request your refund or repair — edit it as you like.
Subject: Recall Z-0324-2024 — Convergent Dental Convergent Dental Hello, I own a Convergent Dental that is covered by recall Z-0324-2024 from Convergent Dental. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
