Monitron II Waveform Analyzer — Class II medical device recall Z-0259-2024
Completed recall by Percussionaire Corporation, reported 2023-11-15, distributed in CA, MD, MS, ND. Note this recall occurred in 2020 and 2021. Reports of screen freeze on visual displays of waveform analyzers
| Recall number | Z-0259-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | Percussionaire Corporation, Sandpoint, ID, United States |
| Recall initiated | 2020-09-14 |
| Classified | 2023-11-07 |
| Reported by FDA | 2023-11-15 |
| Distributed | CA, MD, MS, ND |
| Quantity | 212 |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00849436000068 |
| Serial numbers | WF21150, WF21158, WF21159, WF21163, WF21164, WF21165, WF21166, WF21167, WF21168, WF21169, WF21170, WF21171, WF21172, WF21173, WF21174, WF21175, WF21176, WF21177, WF21178, WF21179, WF21182, WF21183, WF21184, WF21185, WF21186 and 187 more |
| Model numbers | S00015-1 |
Product
Monitron II Waveform Analyzer, REF: S00015-1, used with ventilators.
Reason for recall
Note this recall occurred in 2020 and 2021. Reports of screen freeze on visual displays of waveform analyzers that are paired with ventilators. Subsequently, waveform analyzers were serviced to install PAL microprocessor chips and firmware.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0259-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.