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Recall Observatory FDA recall evidence

Device product

The Hero Model 100 (H-100) is a system consisting of a smart pill dispenser and a medication management app.

Z-2443-2021

July 02, 2021

Class II

Product summary

Firm
Hero Health
Event
Event 88389
Status
Terminated
Classification
Class II
Quantity
12,039 units which had software version V2.04.012
Official record key
device-enforcement:Z-2443-2021

Official wording

Reason: Due to dispenser prompting for a missed dose that had already been dispensed

Code information: Model 100 (H-100) Catalog Number: F00002 Hero 100 V1.4

Distribution pattern: U.S. Nationwide distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Due to dispenser prompting for a missed dose that had already been dispensed