Reported May 18, 2022 · Ongoing
4 Series CX phototherapy units equipped with Daavlin's ClearLink Control System software versions v3.03h and 3.04v. M4…
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?
- 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 codes and dates
- UDI-DI+B2809807QS0020CX60L
- Serial NumberQS11571PLNBCX0020
- Amount recalled
- 1
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.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Daavlin Distributing Company recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.