FDAApril 26, 2022device
4 Series CX phototherapy units equipped with Daavlin's ClearLink Control System software versions v3.03h and 3.04v. M4 Ser CX 311-20 120-240V 50/60Hz, item # 807QS0020CX6.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Ongoing
Brands named
daavlin distributingdaavlin
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAPhothera 200, Phototherapy Devices indicated for use to treat diagnosed skin disorders such as, but not limited to, Psoriasis, Vitiligo, and Atopic Dermatitis (Eczema) under the direction of a physician, Model Numbers 210NDT4 and 210NCL42025-12-10
- FDACrown Point Shelled Edamame, net wt. 22lbs. UPC 813973 01840 4. Product is packaged in carton box with poly liner. Distributed by Alpine Foods Distributing Inc. Milwaukie, OR. Product of China.2025-06-13
- CPSCHomedics Recalls Massagers Due to Fire and Burn Hazards2024-01-04
- FDA1 Series CX phototherapy units equipped with Daavlin's ClearLink Control System software versions v3.03h and 3.04v. Models: [1 Ser CX 305-4 120-240V 50/60Hz, item # 06OS0004CX6], [1 Ser CX 311-4 120-240V 50/60Hz CE, item # 807OS0004CX5], [1 Ser CX 311-4 120-240V 50/60Hz, item # 807OS0004CX6], [1 ...2022-04-26
- FDACaribou Coffee Turkey Sandwich, Net Wt. 9.0oz. (255g)2021-02-26
- FDAFresh Thyme Taco Dip, Net Wt. 10oz (283g), UPC 8 41330 12368 32021-02-26
- FDAEarthgrown Mini Taco Dip, Net Wt. 8oz. (227g), UPC 6 10014 22341 0, Packed By J&J Distributing Inc. 653 Rice St, St Paul, MN 551032021-02-26
- FDATaco Platter [Kwik Trip], Net Wt. 15.8oz (448g), UPC 0 38232 36090 6, Distributed By H. Brooks & Co. Mpls MN 551122021-02-26
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