Recall Z-0324-2024 ยท NVK Laser, Dental, Soft Tissue
Convergent Dental
Solea Models 2.0 and 3.0 Laser Surgical Instrument, Foot Pedal assembly SUB-00434 with foot pedal CUS-00226 Rev. K reworked
| Date | Nov 17, 2023 (initiated Sep 1, 2023) |
| Status | Open, Classified |
| Reason | It has been found that potential unintended laser activation can occur without foot pedal depression. |
| Root cause | Under Investigation by firm |
| Action | An URGENT: MEDICAL DEVICE RECALL notification letter dated 9/1/23 was sent to customers. Please discontinue use of this product until your replacement foot pedal arrives. A replacement foot pedal (part number CUS-00226 Rev Q) will be shipped to the address that we have on file for your office and should arrive no later than September 6, 2023. Your shipment tracking number is [Insert]. A return shipping label will be included in the package. Please send back your original foot pedal for inspection and monitored disposal. Connecting the replacement foot pedal will resolve this issue with no fu |
| Quantity | 39 units |
| Distribution | Worldwide - US Nationwide distribution in the states of AK, AL, CA, CT, FL, KY, ME, MI, MO, MT, NC, OH, OR, PA, TN, TX, UT, VA, WA, WI and the country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K221761 | Solea Convergent Dental, Inc., Sep 14, 2022 |