The Recall Desk
HighFDA (Devices)·Z-1074-2022·Announced 2022-05-18

Phototherapy Units Recalled for Software Bug Causing Incorrect Dosing

Daavlin's 4 Series CX phototherapy units are recalled due to a software defect that can cause incorrect dosing (over or under) when resuming interrupted treatments.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall for a medical device with a software defect that can cause incorrect dosing in phototherapy units. Although no illnesses or injuries have been reported, the defect presents a risk of harm from over or under exposure to therapeutic ultraviolet light.

Plain-English summary

Daavlin's 4 Series CX phototherapy units, equipped with ClearLink Control System software versions v3.03h and 3.04v, are being recalled due to a software defect. When treatment is interrupted and then resumed, the software incorrectly swaps the calibrated treatment distance from 0 inches to 9 inches, resulting in over or under dosing.

The affected units have been distributed worldwide, including throughout the United States and in Canada and Australia. Affected units bear item number 807QS0020CX6. Users should contact Daavlin Distributing Company for guidance on software updates or device replacement.

The recalled product

Product
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.
Manufacturer
Daavlin Distributing Company
Category
Medical Device — Phototherapy Equipment
Hazard
  • software-defect
  • incorrect-dosing

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • UDI-DI: +B2809807QS0020CX60L. Serial Number: QS11571PLNBCX0020

Distribution

Distributed nationwide across the United States.

Related recalls

Same category