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.
The agency’s classification
FDA (Devices): Class II
Class II is 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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- Affected units
- 1
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
Part of a larger recall action
This product is one of 2 recalled by Daavlin Distributing Company under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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