FDA Recall Terminated

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

Recall: Z-2443-2021 · Initiated July 2, 2021

Recall

Recall Number
Z-2443-2021
Event Number
88389
Firm
Hero Health
FEI Number
3014660737
Product Code
NXB
Status
Terminated
Root Cause
Under Investigation by firm
Initiated
July 2, 2021
Terminated
November 2, 2023
Address
20902 Corsair Boulevard, Hayward, CA, 94545

Description

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

Reason

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

Action

On 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 [email protected] (24/7).

Distribution

U.S. Nationwide distribution.

Quantity

12,039 units which had software version V2.04.012