Recall Z-2443-2021 ยท NXB Dispenser, Solid Medication
Hero Health
The Hero Model 100 (H-100) is a system consisting of a smart pill dispenser and a medication management app.
| Date | Jul 2, 2021 |
| Status | Terminated |
| Reason | Due to dispenser prompting for a missed dose that had already been dispensed |
| Root cause | Under Investigation by firm |
| 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 h |
| Quantity | 12,039 units which had software version V2.04.012 |
| Distribution | U.S. Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.