Reported May 18, 2022 · Ongoing
1 Series CX phototherapy units equipped with Daavlin's ClearLink Control System software versions v3.03h and 3.04v.…
Daavlin Distributing Company
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: Daavlin Distributing Company · 205 W Bement St · Bryan, OH · 43506-1264
Is this the product you have?
1 Series CX phototherapy units equipped with Daavlin's ClearLink Control System software versions v3.03h and 3.04v. Models
5 of 5 products
| Model / number | Product as published |
|---|---|
06OS0004CX6 | ], [1 Ser CX 311-4 120-240V 50/60Hz CE |
807OS0004CX5 | ], [1 Ser CX 311-4 120-240V 50/60Hz |
807OS0004CX6 | ], [1 Ser CX 350-4 120-240V 50/60Hz |
807OS0400CX6 | ], [1 Ser CX UVA1-4 120-240V 50/60Hz |
807OS0400CX6A1 | ] |
- Lot codes and dates
- UDI-DI
+B2809806OS0004CX60K+B2809807OS0004CX50K+B2809807OS0004CX60L+B2809807OS0400CX60Land +B2809807OS0400CX6A10W
- Serial Numbers
216 of 216 codes
OS22183PLNBCX0004OS22320PLNBCX0004OS23725PLNBCX0004OS24083PLNBCX0004OS24089PLNBCX0004OS24090PLNBCX0004OS23532PLA1CX0400OS22097PLNBCX0004OS22200PLNBCX0004OS22265PLNBCX0004OS22270PLNBCX0004OS22304PLNBCX0004OS22739PLNBCX0004OS22788PLNBCX0004OS22795PLNBCX0004OS23239PLNBCX0004OS23609PLNBCX0004OS23894PLNBCX0004OS24017PLNBCX0004OS24254PLNBCX0004OS24810PLNBCX0004OS21997PLNBCX0004OS22060PLNBCX0004OS22063PLNBCX0004OS22273PLNBCX0004OS22309PLNBCX0004OS22637PLNBCX0004OS22680PLNBCX0004OS22736PLNBCX0004OS22738PLNBCX0004OS22770PLNBCX0004OS22789PLNBCX0004OS22796PLNBCX0004OS22919PLNBCX0004OS22977PLNBCX0004OS22980PLNBCX0004OS22983PLNBCX0004OS23244PLNBCX0004OS23252PLNBCX0004OS23440PLNBCX0004OS23681PLNBCX0004OS23724PLNBCX0004OS23762PLNBCX0004OS23855PLNBCX0004OS23856PLNBCX0004OS24008PLNBCX0004OS24077PLNBCX0004OS24104PLNBCX0004OS24107PLNBCX0004OS24109PLNBCX0004OS24113PLACX0400OS24127PLNBCX0004OS24308PLNBCX0004OS24310PLNBCX0004OS24376PLNBCX0004OS24467PLNBCX0004OS24478PLNBCX0004OS24229PLACX0400OS22663PLNBCX0004OS23940PLNBCX0004
- UDI-DI
- Amount recalled
- 216
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Software issue, resuming an interrupted treatment will result in swap of utilized calibration treatment distance 0" inches to "9. Resulting in over or under dosing.
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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