Monitron II Waveform Analyzer Screen Freeze Defect in Ventilator Models
Percussionaire Corporation recalled 212 Monitron II Waveform Analyzers due to screen freeze issues on visual displays. Affected units were serviced with PAL microprocessor chips and firmware updates.
The agency’s classification
FDA (Devices): Class II
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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II medical device recall with reported screen freeze defects but no documented illnesses or injuries. The hazard—display freeze on a ventilator-monitoring device—presents a potential risk of harm through impaired patient monitoring, but actual patient harm has not been reported, fitting the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Percussionaire Corporation recalled the Monitron II Waveform Analyzer (REF: S00015-1), a ventilator-paired medical device used to monitor respiratory waveforms. The recall involved 212 units distributed in California, North Dakota, Mississippi, and Maryland.
The recall was initiated due to reports of screen freeze on the waveform analyzer's visual display. When the display froze, users could not visually monitor the waveform data from the paired ventilator, potentially affecting patient monitoring. The manufacturer addressed this issue by servicing affected units to install PAL microprocessor chips and updated firmware.
Affected units were serviced to install the corrective components. Customers with units matching the provided serial numbers should verify that their device has received this service update.
The recalled product
- Product
- Monitron II Waveform Analyzer, REF: S00015-1, used with ventilators.
- Manufacturer
- Percussionaire Corporation
- Affected units
- 212
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- UDI-DI: 00849436000068
- Serial Numbers: WF21150
- WF21159
- WF21163
- WF21164
- WF21167
- WF21171
- WF21371
- WF21372
- WF21377
- WF21378
- WF21158
- WF21391
- WF21165
- WF21166
- WF21168
- WF21169
- WF21170
- WF21172
- WF21173
Distribution
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