Recall Z-1074-2022— Daavlin Distributing Company

Name: FDA recall Z-1074-2022
Creator: U.S. Food and Drug Administration
Published: 2022-04-26

Class II · Ongoing

Class II FDA medical device recall by Daavlin Distributing Company, initiated 2022-04-26. It names one FDA 510(k) clearance: K111172. 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.. 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: Daavlin Distributing Company
Classification: Class II
Status: Ongoing
Initiated: 2022-04-26
Firm location: Bryan, OH, United States

510(k) clearances named in this recall

1 on FDA's record

K111172 — 4 SERIES PHOTOTHERAPY UNIT MODEL 4 SERIESDaavlin Distributing Co.·cleared 2011-08-29

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product 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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.