Food, drugs, devices › Percussionaire Corporation
Device recall: Monitron II Waveform Analyzer, REF: S00015-1, used with ventilators.
FDA enforcement event 93192 is a device recall by Percussionaire Corporation of Sandpoint, ID, initiated 14 Sep 2020 and classified Class II, with 1 product record.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 93% of the 916 device enforcement events initiated in 2020 carry the same class.
Status: Completed. Initiation: voluntary: firm initiated. Percussionaire Corporation has 7 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Percussionaire Corporation, Sandpoint, ID.
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."
Distribution
"US: CA, ND, MS, MD"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0259-2024 | Monitron II Waveform Analyzer, REF: S00015-1, used with ventilators. | 212 | Class II | Completed | 15 Nov 2023 |
Context
Other enforcement events for Percussionaire Corporation
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 17 Sep 2025 | Phasitron 5, IPV In-Line Valve, (Intrapulmonary Percussive Ventilation) REF: P5-TEE-20 (pack of 20)/ P5-TEE (individual) | Device | Class I | 1 |
| 23 Dec 2024 | VDR4 Phasitron Breathing Circuit Models that contain the venturi component: -A50094 D 5PK, Phasitron Kit, VDR, Single Pa | Device | Class I | 1 |
| 16 Sep 2024 | Phasitron5 Breathing Circuit (P5-10, P5-HC, P5-UC-10). component of Intrapulmonary Percussive Ventilation, used to provi | Device | Class I | 1 |
| 21 Aug 2024 | Percussionaire, Inc., REF: P5-TEE, Qty: 1, Rx Only. IPV (Intrapulmonary Percussive Ventilation) therapy In-Line Valve | Device | Class I | 2 |
| 12 Dec 2023 | High Frequency Transport Phasitron Breathing Circuit Kit REF: A50605-D, Rx Only, CE 0123 | Device | Class I | 1 |
| 28 Mar 2023 | Distal Phasitron, Part: S20020, for use with Percussionaire VDR-4 control driver (or control unit) | Device | Class I | 1 |
All 7 events for Percussionaire Corporation
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "US: CA, ND, MS, MD"
Is the recall still ongoing?
FDA lists the status as Completed. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.