Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1073-2022 — 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

U.S. FDA — Device Enforcement · United States · 2022-04-26 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1073-2022
Date of alert
2022-04-26
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Daavlin Distributing Company
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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