Daavlin 1 Series CX Phototherapy Units Recalled for Software Dosing Error
Daavlin is recalling 1 Series CX phototherapy units due to a software bug that swaps calibration distance settings when resuming interrupted treatments, resulting in incorrect dosing.
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: This is a risk-of-harm medical device where a confirmed software defect creates potential for incorrect dosing. No illnesses or injuries have been reported in the source, and FDA Class II recalls without reported harm typically score at 3 per the rubric.
Plain-English summary
Daavlin Distributing Company is recalling 1 Series CX phototherapy units equipped with ClearLink Control System software versions v3.03h and 3.04v. A total of 216 units were distributed worldwide, including across most US states, Australia, and Canada.
The recall addresses a software defect that occurs when resuming an interrupted treatment. The software swaps the calibration treatment distance from 0 inches to 9 inches or vice versa, resulting in over or under dosing.
The affected models are 1 Series CX 305-4, 1 Series CX 311-4, 1 Series CX 350-4, and 1 Series CX UVA1-4 (all 120-240V 50/60Hz configurations). Healthcare facilities and practitioners should verify their units against the provided serial numbers and UDI codes in the FDA recall notice.
The recalled product
- Product
- 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
- Manufacturer
- Daavlin Distributing Company
- Hazard
- software-defect
- dosing-error
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 (20)
- UDI-DI: +B2809806OS0004CX60K
- +B2809807OS0004CX50K
- +B2809807OS0004CX60L
- +B2809807OS0400CX60L
- and +B2809807OS0400CX6A10W. Serial Numbers: OS22183PLNBCX0004
- OS22320PLNBCX0004
- OS23725PLNBCX0004
- OS24083PLNBCX0004
- OS24089PLNBCX0004
- OS24090PLNBCX0004
- OS23532PLA1CX0400
- OS22097PLNBCX0004
- OS22200PLNBCX0004
- OS22265PLNBCX0004
- OS22270PLNBCX0004
- OS22304PLNBCX0004
- OS22739PLNBCX0004
- OS22788PLNBCX0004
- OS22795PLNBCX0004
- OS23239PLNBCX0004
Distribution
Distributed nationwide across the United States.
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