Convergent Dental Recalls Five Solea 1.0 Laser Surgical Instruments
Convergent Dental is recalling five Solea 1.0 laser surgical instruments due to a defect that could cause unintended laser emission during activation.
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: The recall involves a high-risk medical device with a defect that could cause unintended laser emission, posing a risk of harm, but the source text does not report any specific injuries or illnesses.
Plain-English summary
Convergent Dental is recalling five units of the Solea 1.0 Laser Surgical instrument. This device is intended for use in general and plastic surgery and dermatology. The recall involves specific serial numbers: CDS1-DVSU-1B-JU-13, CDS1-7QRE-1B-JU-13, CDS1-22TZ-1B-JU-13, CDS1-PNJZ-1B-AU-13, and CDS1-A4CQ-1B-AU-13.
The recall is being conducted because a specific error condition could lead to unintended laser emission during laser activation. This defect presents a potential safety risk to patients and operators during surgical procedures.
The affected units were distributed in the United States, specifically in the states of Massachusetts, Connecticut, and New York. Users of these devices should contact Convergent Dental for instructions on how to resolve the issue.
The recalled product
- Product
- Solea 1.0 Laser Surgical instrument for use in general and plastic surgery and dermatology.
- Manufacturer
- Convergent Dental
- Affected units
- 5
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 (5)
- 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
Distribution
Related recalls
Same manufacturer · Convergent Dental
See all →- HighSolea Laser Surgical Instrument Models 2.0 and 3.0 Recall for Unintended Activation
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