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
No recalls linked.
Regulatory clearances
Predicate lineage
- K120907
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 |
|---|---|---|---|---|
| 2026-04-30 | WL | Warning Letter | ZOLL Medical Corporation | — |
| 2026-04-30 | WL | Warning Letter | ZOLL Medical Corporation | — |
| 2025-07-24 | VAI | Voluntary action indicated | ZOLL Medical Corporation | 0 |
| 2025-07-24 | VAI | Voluntary action indicated | ZOLL Medical Corporation | 0 |
| 2025-04-15 | OAI | Official action indicated | ZOLL Medical Corporation | 5 |
| 2025-04-15 | OAI | Official action indicated | ZOLL Medical Corporation | 5 |
| 2024-02-13 | VAI | Voluntary action indicated | ZOLL Circulation, Inc. | 0 |
| 2024-02-13 | VAI | Voluntary action indicated | ZOLL Circulation, Inc. | 0 |
| 2022-06-13 | VAI | Voluntary action indicated | Zoll Medical Corporation | 5 |
| 2022-06-13 | VAI | Voluntary action indicated | Zoll Medical Corporation | 5 |
| 2022-04-08 | NAI | No action indicated | Vyaire Medical, Inc. | 0 |
| 2022-03-10 | VAI | Voluntary action indicated | ZOLL Medical Corporation | 4 |
| 2022-03-10 | VAI | Voluntary action indicated | ZOLL Medical Corporation | 4 |
| 2017-11-09 | VAI | Voluntary action indicated | ZOLL Circulation, Inc. | 3 |
| 2017-10-25 | VAI | Voluntary action indicated | ZOLL Medical Corporation | 5 |
| 2017-10-25 | VAI | Voluntary action indicated | ZOLL Medical Corporation | 5 |
| 2017-05-05 | NAI | No action indicated | Vyaire Medical, Inc. | 0 |
| 2016-10-18 | VAI | Voluntary action indicated | ZOLL Medical Corporation | 0 |
| 2016-10-18 | VAI | Voluntary action indicated | ZOLL Medical Corporation | 0 |
| 2016-08-26 | NAI | No action indicated | ZOLL Medical Corporation | 0 |
| 2016-08-26 | NAI | No action indicated | ZOLL Medical Corporation | 0 |
| 2016-04-08 | NAI | No action indicated | ZOLL Medical Corporation | 0 |
| 2011-04-22 | WL | Warning Letter | ZOLL Medical Corporation | — |
| 2011-04-22 | WL | Warning Letter | ZOLL Medical Corporation | — |
| 2010-09-30 | WL | Warning Letter | ZOLL Medical Corporation | — |
| 2010-09-30 | WL | Warning Letter | ZOLL Medical Corporation | — |
| 2010-02-05 | WL | Warning Letter | Zoll Medical Corporation | — |
| 2010-02-05 | WL | Warning Letter | Zoll Medical Corporation | — |
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