Lutronic CLARITY II Laser System recalled for sparking and burn hazard
The Lutronic CLARITY II Laser System (Model 1110200210) may spark or pop during use, potentially causing burns to patients. The FDA has identified over 1,500 affected units based on serial number.
From the FDA notice · Read the official notice ↗
What to do
- Stop using the device immediately if you own or operate one of the affected serial numbers.
- Contact Lutronic Corporation for instructions on safe return or replacement.
- Check the device serial number against the recall list to confirm if your unit is affected.
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- CLARITY II Laser System; Model No. 1110200210.
- Sold in
- Nationwide
- Made for
- All ages (0 months and older)
Details
- Units affected
- 1,525 units
- Illnesses reported
- None reported
- Manufactured in
- 219 Sowon-Ro; Deogyang, N/A, Goyang, N/A, Korea (the Republic of)
- Classification
- Class II
- Recall number
- Z-1558-2026
In the FDA's words
- Description
- CLARITY II Laser System; Model No. 1110200210. Reports of devices sparking/popping and potentially burning patients. Model No. 1110200210; UDI: 08809447653723; Serial No. C3023K024, C3022B006, C3025D028, C3022L031, C3024D027, C3022H015, C3024K033, C3019J018, C3024K030, C3025B076, C3023K043, C3021K002, C3025E050, C3025E035, C3022L010, C3023G009, C3023J037, C3021D021, C3020C010, C3019L007, C3025B011, C3025B012, C3022G011, C3022F020, C3025D076, C3024J038, C3025E041, C3021L005, C3025C022, C3024G026, C3023B044, C3021F012, C3024G008, C3024D025, C3025E065, C3024F030, C3022H021, C3022H022, C3025C029, C3023L034, C3023L070, C3023D060, C3024H029, C3025D094, C3023L043, C3022M010, C3023C008, C3025D085, C3022J035, C3022K009, C3023K035, C3025B071, C3021F001, C3023J006, C3022L026, C3022J033, C3023J004, C3024G004, C3022D023, C3025E028, C3021L031, C3023K048, C3025D080, C3019M006, C3022A003, C3023K027, C3021K020, C3022K023, C3025D035, C3023J029, C3022E030, C3021L007, C3025B078, C3023J041, C3023A020, C3025E038, C3023H019, C3025C034, C3024J041, C3025E047, C3025D097, C3022E026, C3024J089, C3025B033, C3023B002, C3023B040, C3023B018, C3022K007, C3024F012, C3022G015, C3022J024, C3025B118, C3024J088, C3023L010, C3022F014, C3022F015, C3024J078, C3023L041, C3020K009, C3019J007, C3020K012, C3023B035, C3024J046, C3025D040, C3024J047, C3020J012, C3024J091, C3025D039, C3024M058, C3020L006, C3023E026, C3023E027, C3022K020, C3023L027, C3020L008, C3022L040, C3024G014, C3023M020, C3025E091, C3022A032, C3022B012, C3025E095, C3025C019, C3025C020, C3025C017, C3025C018, C3024D002, C3024C017, C3022J011, C3020H003, C3023H016, C3024C013, C3022A009, C3022J030, C3021F013, C3023E029, C3021M005, C3025E027, C3022K008, C3023K046, C3023D015, C3024G022, C3025B003, C3025E073, C3023L012, C3024H016, C3024J043, C3021G022, C3019K005, C3023G031, C3023E037, C3025E033, C3023M024, C3025D105, C3023F021, C3025E060, C3024F013, C3022E029, C3024K051, C3024J086, C3025C035, C3023E024, C3024J045, C3023J042, C3025B028, C3023F025, C3023L035, C3023C013, C3023D049, C3023D048, C3021J003, C3023F015, C3025E034, C3023A019, C3020G002, C3023D041, C3023D045, C3025D099, C3023G013, C3023D018, C3024M055, C3023C012, C3023F022, C3025C026, C3022L038, C3024H031, C302J009, C3025E032, C3024K117, C3022K006, C3024G017, C3024J049, C3022F001, C3023J017, C3022J027, C3021A007, C3023A024, C3024H077, C3024K016, C3025B079, C3023D002, C3022A033, C3023F020, C3023F019, C3022L036, C3023M021, C3024G018, C3025D084, C3025E006, C3024H021, C3024J036, C3022H013, C3025B118, C3024M060, C3024J075, C3022F019, C3019M009, C3019K003, C3023L039, C3024H016, C3022M016, C3024K113, C3022J028, C3022L056, C3022H014, C3022C011, C3021K004, C3024H079, C3025B074, C3024K054, C3023K031, C3022H020, C3024H074, C3023K030, C3022B005, C3025D081, C3024G010, C3025E056, C3021D018, C3021L030, C3025E025, C3019M001, C3021J001, C3021M018, C3022K019, C3021L008, C3021G020, C3019K009, C3023E035, C3022J029, C3021A008, C3025D102, C3024K114, C3022E020, C3020L003, C3023L044, C3024J042, C3023E038, C3023L068, C3022M004, C3023E040, C3024D031, C3019M007, C3023K042, C3024J054, C3024K023, C3023C016, C3023C020, C3024K035, C3022A007, C3023D044, C3023B005, C3022C009, C3024J081, C3023L069, C3022L003, C3024H028, C3019K004, C3025D030, C3024H061, C3024C018, C3025E011, C3025E052, C3021M007, C3025E075, C3025D083, C3025E054, C3020C007, C3025D101, C3024J044, C3024H030, C3025D043, C3023J036, C3025B072, C3025D082, C3023H017, C3024D028, C3023D014, C3022F010, C3023A026, C3025D096, C3023L037, C3024E007, C3025B115, C3024K111, C3023J005, C3025B113, C3023J039, C3023J011, C3023D021, C3019K008, C3024H015, C3024J090, C3023E023, C3023D059, C3023K022, C3022F005, C3024H041, C3023C018, C3023A022, C3023L033, C3025B073, C3025D095, C3022L033, C3023J014, C3022J025, C3019L004, C3025B009, C3025E051, C3020G003, C3024E009, C3024H014, C3022F021, C3025B111, C3022J002, C3022L041, C3021K021, C3025E023, C3025E071, C3022L049, C3024C019, C3023L019, C3023K049, C3023C010, C3020J005, C3021M011, C3021K003, C3023H014, C3022M006, C3023A021, C3021M010, C3025E029, C3023D012, C3020G008, C3024G024, C3025D103, C3024D023, C3023L073, C3022D025, C3024H034, C3023C006, C3022L039, C3024K116, C3024H024, C3021D017, C3023B004, C3024H071, C3021J033, C3022H025, C3024H033, C3021H017, C3025D098, C3023K034, C3023G025, C3024J003, C3024K020, C3019M008, C3025B037, C3025B036, C3022E016, C3022M009, C3025E049, C3023G026, C3023D008, C3024F011, C3025E039, C3022F012, C3023B041, C3024K057, C3025D065, C3024H075, C3023B042, C3024D026, C3021F011, C3024J035, C3024K021, C3021F008, C3023L014, C3024H020, C3023G016, C3020G009, C3024E005, C3025D061, C3022L057, C3020J013, C2014K002, C3023E041, C3025E074, C3025D045, C3025D086, C3024K022, C3025E036, C3025D027, C3023C017, C3022A002, C3025D036, C3023D016, C3023F016, C3024G016, C3025E076, C3025B119, C3023K044, C3022L018, C3024H040, C3024K027, C3019L001, C3025E013, C3020J004, C3023B010, C3022E014, C3022J008, C3022E017, C3022A034, C3023J034, C3024K034, C3024H068, C3023J043, C3023L076, C3022H024,
- Hazard
- Reports of devices sparking/popping and potentially burning patients.
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