4 Series CX phototherapy units equipped with Daavlin's ClearLink Control System software versions v3.03h and 3.04v. M4
Summary
The FDA issued a Class II for 4 Series CX phototherapy units equipped with Daavlin's ClearLink Control System by Daavlin Distributing Company. Reason: Software issue, resuming an interrupted treatment will result in swap of utilized calibration treatment distance 0" inches to "9. Resulting in over or.
Details
Source
Device Recall
External ID
Z-1074-2022
Action Date
2022-05-18
Status
Ongoing
Category
device
Product Description
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.
Lot/Code Info: UDI-DI: +B2809807QS0020CX60L. Serial Number: QS11571PLNBCX0020
Quantity Affected: 1
Reason for Recall
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.
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, SD, TN, TX, VA, WA, WI, WV and the countries of Australia, Canada.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-04-26
Company
Bryan, OH
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 140 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Daavlin Distributing Company has 3 FDA actions in our database, including 3 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Daavlin Distributing Company) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Daavlin Distributing Company have FDA actions?
Daavlin Distributing Company has 3 FDA actions in our database, including 3 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1074-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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