Solea Models 2.0 and 3.0 Laser Surgical Instrument, Foot Pedal assembly SUB-00434 with foot pedal CUS-00226 Rev. K rewo
Summary
The FDA issued a Class II for Solea Models 2.0 and 3.0 Laser Surgical Instrument, Foot Pedal assembly SUB-0043 by Convergent Dental. Reason: It has been found that potential unintended laser activation can occur without foot pedal depression..
Details
Source
Device Recall
External ID
Z-0324-2024
Action Date
2023-11-29
Status
Ongoing
Category
device
Product Description
Solea Models 2.0 and 3.0 Laser Surgical Instrument, Foot Pedal assembly SUB-00434 with foot pedal CUS-00226 Rev. K reworked
Lot/Code Info: 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, 0310535, 0310536, 0310537, 0310538, 0310539, 0310540, 0310541, 0310542, 0310543, 0310317, 0310321, 0310322, 0300730; Solea Model 2.0: UDI-DI: 00850634007001; Serial Numbers: 0200822, 0200807, 0200810, 0200625, CDS2-U33W-1B-DE-15, 0200819, 0200401
Quantity Affected: 39 units
Reason for Recall
It has been found that potential unintended laser activation can occur without foot pedal depression.
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-09-01
Company
Needham, MA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 167 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Convergent Dental) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Convergent Dental have FDA actions?
This is the only FDA action we have on record for Convergent Dental in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0324-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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