Recall – Resuming interrupted treatment can result in over/under dosing

Company: Daavlin Distributing Company
Date of Enforcement Report: 5/18/2022
Class II

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 # 807OS0004CX6
  • 1 Ser CX 350-4 120-240V 50/60Hz, item # 807OS0400CX6
  • 1 Ser CX UVA1-4 120-240V 50/60Hz, item # 807OS0400CX6A1

Recall Number:

Z-1073-2022

REASON

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.

RECALLING FIRM/MANUFACTURER

Daavlin Distributing Company on 5/18/2021. Voluntary: Firm initiated

VOLUME OF PRODUCT IN COMMERCE

216

DISTRIBUTION

U.S. Nationwide and International

Latest News!

Updated Risk Management training course now available.  Includes:

  • Coverage of ISO 14971, IEC 62304; amd1, and IEC/TR 80002-1.
  • Why FMEA is incomplete for medical device risk management.
  • How to perform software hazards analysis.
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Corporate Office

15148 Springview St.
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN, TX) and Canada.