Reported Nov 29, 2023 · Ongoing
Solea Models 2.0 and 3.0 Laser Surgical Instrument, Foot Pedal assembly SUB-00434 with foot pedal CUS-00226 Rev. K…
Convergent Dental
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Convergent Dental · 140 Kendrick St Bldg C3 · Needham, MA · 02494-2739
Is this the product you have?
- Solea Models 2.0 and 3.0 Laser Surgical Instrument, Foot Pedal assembly SUB-00434 with foot pedal CUS-00226 Rev. K reworked
- Lot codes and dates
- Solea Model 3.0:
- UDI-DI00850634007018
- Serial Numbers
03105160310517031051803105190310520031052103105220310523031052403105250310526031052703105280310529031053003105310310532031053303105340310535031053603105370310538031053903105400310541031054203105430310317031032103103220300730Solea Model 2.0:
- UDI-DI00850634007001
- Serial Numbers
0200822020080702008100200625CDS2-U33W-1B-DE-1502008190200401
- Amount recalled
- 39 units
Where it was sold
Why it was recalled
It has been found that potential unintended laser activation can occur without foot pedal depression.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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