Device recall: 1 Series CX phototherapy units equipped with Daavlin's ClearLink Control System software versions v3.03h and 3.04v.…

Class II FDA enforcement event 89990. Recall start date: 26 Apr 2022. Status in the FDA record: Ongoing.

Reason for recall, in the words of FDA

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.

Class II, in the words of FDA

a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote

Daavlin Distributing Company started this device recall on 26 Apr 2022. The firm address in the FDA record is in Bryan, OH. FDA put the recall in Class II. FDA event 89990 has 2 product records. The first FDA enforcement report date is 18 May 2022. The record gives the status Ongoing.

FDA enforcement report The 2 product records

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

Worldwide distribution - US Nationwide distribution in the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NY, OH, OK, OR, PA,…

Recalling firm

Daavlin Distributing Company, Bryan, OH.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

2 product records in the event.

FDA event 89990: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-1073-2022	1 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 Ser CX 350-4 120-240V…	216	Class II	Ongoing	18 May 2022
Z-1074-2022	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.	1	Class II	Ongoing	18 May 2022

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Device events that started in 2022: 839
Share of these events in Class II: 88%
Product records in this event: 2Median of the firm: 2
Events of the firm on the register: 3

Other events of the firm

Other FDA enforcement events of Daavlin Distributing Company
Initiated	Product (first record)	Type	Class	Records
5 Mar 2026	Photera 400, phototherapy device; Ultraviolet Lamp For Dermatologic Disorders	Device	Class II	3
10 Dec 2025	Phothera 200, Phototherapy Devices indicated for use to treat diagnosed skin disorders such as, but not limited to, Psor	Device	Class II	1

Daavlin Distributing Company: all 3 events

Official channels

FDA enforcement report Z-1073-2022The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

Follow by RSS:Food, drug and device recallsFDA Class I recalls

Cite this page

Recall Register. FDA enforcement event 89990. https://recallregister.com/fda/ii/89990/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA device enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: Worldwide distribution - US Nationwide distribution in the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NY, OH, OK, OR, PA,…
What quantity of product is in FDA event 89990?: The event has 2 product records. The first record gives this quantity: 216
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2022 have the same class?: 88% of the 839 device events that started in 2022 are in Class II.