Adverse-event reports (MAUDE)
Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.
No adverse-event reports are linked to this device.
Recall history
| Initiated | Recall # | Class | Status | Reason | Quantity | Link basis |
|---|---|---|---|---|---|---|
| 2024-08-13 | Z-3099-2024 | Class II | Open, Classified | This product labeling does not adequately provide warning about the risks associated with the use of damaged batteries or batteries past the intended use life.Distribution: awaiting additional details | 1506 units | code info di |
Regulatory clearances
Predicate lineage
Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2024-05-31 | VAI | Voluntary action indicated | Zoe Medical Incorporated | 5 |
| 2024-05-31 | VAI | Voluntary action indicated | Zoe Medical Incorporated | 5 |
| 2019-09-20 | VAI | Voluntary action indicated | Zoe Medical Incorporated | 1 |
| 2019-09-20 | VAI | Voluntary action indicated | Zoe Medical Incorporated | 1 |
| 2016-10-12 | NAI | No action indicated | Zoe Medical Incorporated | 0 |
| 2016-10-12 | NAI | No action indicated | Zoe Medical Incorporated | 0 |
| 2013-02-07 | VAI | Voluntary action indicated | Zoe Medical Incorporated | 1 |
| 2013-02-07 | VAI | Voluntary action indicated | Zoe Medical Incorporated | 1 |
| 2010-04-20 | VAI | Voluntary action indicated | Zoe Medical Incorporated | 4 |
| 2010-04-20 | VAI | Voluntary action indicated | Zoe Medical Incorporated | 4 |
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