FDANovember 1, 2023device
Brand Name: Guardian 2 System Product Name: Guardian System 2 Controller Model/Catalog Number: GS-2.5-C Software Version: 2.5.4-59 (Fix)
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
A software issue where "low" and "terminal" battery alerts did not display on the screen to the user in specific circumstances when the device was not running patient therapy.
What to do
FDA enforcement status: Ongoing
Brands named
turncare
UPCs
00860001236453
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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