Monitron II Waveform Analyzer, REF: S00015-1, used with ventilators.
FDA device recall Z-0259-2024 · posted 2023-11-07 · Completed
Recall details
- Recalling firm
- Percussionaire Corporation
- 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.
- Action taken
- Waveform analyzers were serviced from September 2020 through September 2021.
- Root cause
- Device Design
- Status
- Completed
- Product code
- CBK
- Quantity affected
- 212
- Distribution
- US: CA, ND, MS, MD
- Date initiated
- 2020-09-14
- Date posted
- 2023-11-07
- Location
- Sandpoint, ID
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VDR SINUSOIDAL PERCUSIONATOR FAMILY/RELATE ACCESS (K905235) | Percussionaire Corp. | 1991-05-03 |