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 |
|---|---|---|---|---|---|---|
| 2023-07-25 | Z-2592-2023 | Class II | Open, Classified | During rework of components during the manufacturing process, an additional piece of material may have been left in the device, which may result in an impact on measurement performance.Distribution: US Nationwide distribution. | REVISED 9/21/2023-15,065 packages | code info di |
Regulatory clearances
Predicate lineage
K041548
Cited as predicate by: K232516
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 |
|---|---|---|---|---|
| 2016-04-28 | NAI | No action indicated | SenTec AG | 0 |
| 2016-04-28 | NAI | No action indicated | SenTec AG | 0 |
| 2012-10-25 | NAI | No action indicated | SenTec AG | 0 |
| 2012-10-25 | NAI | No action indicated | SenTec AG | 0 |
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