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U.S. Department of Health and Human Services

Class 2 Device Recall Hero Model 100 (H100)

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 Class 2 Device Recall Hero Model 100 (H100)see related information
Date Initiated by FirmJuly 02, 2021
Create DateSeptember 10, 2021
Recall Status1 Terminated 3 on November 02, 2023
Recall NumberZ-2443-2021
Recall Event ID 88389
Product Classification Dispenser, solid medication - Product Code NXB
ProductThe Hero Model 100 (H-100) is a system consisting of a smart pill dispenser and a medication management app.
Code Information Model 100 (H-100) Catalog Number: F00002 Hero 100 V1.4
Recalling Firm/
Manufacturer		 Hero Health
20902 Corsair Boulevard
Hayward CA 94545
For Additional Information Contact
855-855-9962
Manufacturer Reason
for Recall		Due to dispenser prompting for a missed dose that had already been dispensed
FDA Determined
Cause 2		Under Investigation by firm
ActionOn 07/02/2021, the firm initially sent out an "URGENT NOTICE" via email notifying customers of an product update correction. Customers were informed that the firm had become aware that a recent firmware update (v2.4.12) that users have experienced an error, which caused improper recording of a dispensed dose as having not been dispensed. This error may prompt a user to dispense the same dose again, and the mobile app will indicate that the previously dispensed dose has not been taken yet. Customers are instructed to: -If the pill dispenser prompts you to re-dispense a scheduled dose which has already been dispensed today, select Skip. -Use extra caution when dispensing doses prior to the scheduled firmware update and verify that the pill dispenser has a working internet connection. This will ensure that the firmware update (v2.4.14) will be automatically applied on all potentially affected online pill dispensers (at approximately 2:00 AM on July 3, 2021) to correct the issue. -To manually update firmware immediately, follow these steps: 1) Ensure the Pill Dispenser is connected to WiFi (Check for the WiFi icon on the main screen). 2) Go to the Device menu, by pressing the Center button on the main screen. 3) Scroll down and select Device Settings . 4) Scroll down and select Firmware Update. 5) Select I m Ready. The update could take several minutes. It is recommended to run the firmware update at least 30 minutes before a scheduled dose. -If the pill dispenser is not connected to WiFi, the firmware update cannot be completed. In this event, contact the Recalling Firm's Member support for assistance before continuing to use the pill dispenser to ensure the update is applied as soon as possible For question or further assistance, contact the Recalling firm at 855-855-9962 or via email at hello@herohealth.com (24/7).
Quantity in Commerce12,039 units which had software version V2.04.012
DistributionU.S. Nationwide distribution.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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