Recall Z-0259-2024 ยท CBK Ventilator, Continuous, Facility Use
Percussionaire Corporation
Monitron II Waveform Analyzer, REF: S00015-1, used with ventilators.
| Date | Nov 7, 2023 (initiated Sep 14, 2020) |
| Status | Completed |
| Reason | 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. |
| Root cause | Device Design |
| Action | Waveform analyzers were serviced from September 2020 through September 2021. |
| Quantity | 212 |
| Distribution | US: CA, ND, MS, MD |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K905235 | VDR SINUSOIDAL PERCUSIONATOR FAMILY/RELATE ACCESS Percussionaire Corp., May 3, 1991 |