FDA Device recall Z-0050-2014
Solea 1.0 Laser Surgical instrument for use in general and plastic surgery and dermatology
- FDA Device
- Class II
- terminated
- Published 2013-10-30
On 2013-10-30 the FDA classified a Class II recall of Solea 1.0 Laser Surgical instrument for use in general and plastic surgery and dermatology by Convergent Dental, citing specific error condition could lead to unintended laser emission during laser activation.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0050-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-09-12 |
| Published | 2013-10-30 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Convergent Dental |
| Distribution | CT, MA, NY |
Product
Solea 1.0 Laser Surgical instrument for use in general and plastic surgery and dermatology.
Reason
Specific error condition could lead to unintended laser emission during laser activation.
Identifiers
| code_info | 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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0050-2014%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.