Solea 1 — Class II medical device recall Z-0050-2014
Terminated recall by Convergent Dental, reported 2013-10-30, distributed in CT, MA, NY. Specific error condition could lead to unintended laser emission during laser activation.
| Recall number | Z-0050-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Convergent Dental, Natick, MA, United States |
| Recall initiated | 2013-09-12 |
| Classified | 2013-10-22 |
| Reported by FDA | 2013-10-30 |
| Terminated | 2013-11-15 |
| Distributed | CT, MA, NY |
| Quantity | 5 |
| Serial numbers | CDS1-22TZ-1B-JU-13, CDS1-7QRE-1B-JU-13, CDS1-A4CQ-1B-AU-13, CDS1-DVSU-1B-JU-13, CDS1-PNJZ-1B-AU-13 |
Product
Solea 1.0 Laser Surgical instrument for use in general and plastic surgery and dermatology.
Reason for recall
Specific error condition could lead to unintended laser emission during laser activation.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0050-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.