Solea Laser Surgical Instrument Models 2.0 and 3.0 Recall for Unintended Activation
Convergent Dental is recalling 39 Solea laser surgical instruments due to potential unintended laser activation without foot pedal depression. No injuries have been reported.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device with potential for unintended activation of surgical laser equipment. No injuries or illnesses have been reported, placing this at the risk-of-harm-without-reported-injury threshold per the severity rubric.
Plain-English summary
Convergent Dental is recalling 39 units of its Solea Models 2.0 and 3.0 Laser Surgical Instruments. The recalled instruments are susceptible to unintended laser activation without foot pedal depression, which could lead to accidental discharge during clinical use.
The affected devices have been distributed throughout the United States (Alaska, Alabama, California, Connecticut, Florida, Kentucky, Maine, Michigan, Missouri, Montana, North Carolina, Ohio, Oregon, Pennsylvania, Tennessee, Texas, Utah, Virginia, Washington, and Wisconsin) and Canada. The recall identifies devices with specific serial numbers found in manufacturing records.
No injuries or adverse events have been reported at this time. Practitioners using affected instruments should verify their serial numbers against the recall and contact the manufacturer for further instructions on addressing this defect.
The recalled product
- Product
- Solea Models 2.0 and 3.0 Laser Surgical Instrument, Foot Pedal assembly SUB-00434 with foot pedal CUS-00226 Rev. K reworked
- Manufacturer
- Convergent Dental
- Affected units
- 39
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Solea Model 3.0: UDI-DI: 00850634007018
- Serial Numbers: 0310516
- 0310517
- 0310518
- 0310519
- 0310520
- 0310521
- 0310522
- 0310523
- 0310524
- 0310525
- 0310526
- 0310527
- 0310528
- 0310529
- 0310530
- 0310531
- 0310532
- 0310533
- 0310534
Distribution
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