FDA Recall
Completed
Monitron II Waveform Analyzer, REF: S00015-1, used with ventilators.
Recall: Z-0259-2024
·
Initiated September 14, 2020
Recall
- Recall Number
- Z-0259-2024
- Event Number
- 93192
- Firm
- Percussionaire Corporation
- FEI Number
- 1000524541
- Product Code
- CBK
- Status
- Completed
- Root Cause
- Device Design
- Initiated
- September 14, 2020
- Posted
- November 7, 2023
- Address
- 130 Mcghee Rd, Ste 109, Sandpoint, ID, 83864-8409
Description
Monitron II Waveform Analyzer, REF: S00015-1, used with ventilators.
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.
Action
Waveform analyzers were serviced from September 2020 through September 2021.
Distribution
US: CA, ND, MS, MD
Quantity
212