The Hero Model 100 (H-100) is a system consisting of a smart pill dispenser and a medication management app.
Summary
The FDA issued a Class II for The Hero Model 100 (H-100) is a system consisting of a smart pill dispenser and by Hero Health. Reason: Due to dispenser prompting for a missed dose that had already been dispensed.
Details
Source
Device Recall
External ID
Z-2443-2021
Action Date
2021-09-22
Status
Terminated
Category
device
Product Description
The Hero Model 100 (H-100) is a system consisting of a smart pill dispenser and a medication management app.
Lot/Code Info: Model 100 (H-100) Catalog Number: F00002 Hero 100 V1.4
Quantity Affected: 12,039 units which had software version V2.04.012
Reason for Recall
Due to dispenser prompting for a missed dose that had already been dispensed
Distribution
U.S. Nationwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-07-02
Company
Hayward, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 142 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Hero Health) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Hero Health have FDA actions?
This is the only FDA action we have on record for Hero Health in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2443-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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