Recall Z-0319-2018— ProSun International, LLC

Name: FDA recall Z-0319-2018
Creator: U.S. Food and Drug Administration
Published: 2017-12-02

Class II · Terminated

Class II FDA medical device recall by ProSun International, LLC, initiated 2017-12-02, terminated 2026-02-18. FDA's recall record names no specific 510(k) clearance for this event. Product: Sundream 12 V tanning bed. Reason: The 30 minute maximum tanning time has been reduced to 20 minutes..

Recalling firm: ProSun International, LLC
Classification: Class II
Status: Terminated
Initiated: 2017-12-02
Terminated: 2026-02-18
Firm location: Saint Petersburg, FL, United States

Product description

Sundream 12 V tanning bed

Reason for recall

The 30 minute maximum tanning time has been reduced to 20 minutes.

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