FDASeptember 14, 2020device
Monitron II Waveform Analyzer, REF: S00015-1, used with ventilators.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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 to do
FDA enforcement status: Completed
Brands named
percussionaire
UPCs
00849436000068
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAPhasitron 5, IPV In-Line Valve, (Intrapulmonary Percussive Ventilation) REF: P5-TEE-20 (pack of 20)/ P5-TEE (individual) with In-Line Valve Sentec Instructions for Use2025-09-17
- FDAVDR4 Phasitron Breathing Circuit Models that contain the venturi component: -A50094 D 5PK, Phasitron Kit, VDR, Single Patient, 5pk -A51001, VDR4 Control Unit Tester -PRT 991, VDR W/SWIVEL T SINGLE PATIENT PHASITRON -PRT 992, VDR4 HUMIDIFICATION ADAPTER KIT, CASE OF 10 -PRT 993, VDR4 Humidificatio...2024-12-23
- FDAPhasitron5 Breathing Circuit (P5-10, P5-HC, P5-UC-10). component of Intrapulmonary Percussive Ventilation, used to provide airway clearance therapy2024-09-16
- FDAPercussionaire, Inc., REF: P5-TEE-20, Qty: 20, Rx Only. IPV (Intrapulmonary Percussive Ventilation) therapy In-Line Valve2024-08-21
- FDAPercussionaire, Inc., REF: P5-TEE, Qty: 1, Rx Only. IPV (Intrapulmonary Percussive Ventilation) therapy In-Line Valve2024-08-21
- FDAHigh Frequency Transport Phasitron Breathing Circuit Kit REF: A50605-D, Rx Only, CE 01232023-12-12
- FDADistal Phasitron, Part: S20020, for use with Percussionaire VDR-4 control driver (or control unit)2023-03-28
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