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.
Class I - Dangerous 🏥 Medical Devices
Recalled: April 26, 2022 Daavlin Distributing Company Other Medical Devices
Nationwide
What Should You Do?
- Check if you have this product: UDI-DI: +B2809807QS0020CX60L. Serial Number: QS11571PLNBCX0020
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Daavlin Distributing Company
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full 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.
Product Codes/Lot Numbers:
UDI-DI: +B2809807QS0020CX60L. Serial Number: QS11571PLNBCX0020
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1074-2022
Related Recalls
Class I - Dangerous
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.