Reported Nov 15, 2023 · Completed

Monitron II Waveform Analyzer, REF: S00015-1, used with ventilators.

Percussionaire Corporation

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Percussionaire Corporation · 130 Mcghee Rd Ste 109 · Sandpoint, ID · 83864-8409

Is this the product you have?

  • Monitron II Waveform Analyzer
  • REFS00015-1, used with ventilators
Lot codes and dates
  • UDI-DI00849436000068
  • Serial Numbers

    212 of 212 codes

    • WF21150
    • WF21159
    • WF21163
    • WF21164
    • WF21167
    • WF21171
    • WF21371
    • WF21372
    • WF21377
    • WF21378
    • WF21158
    • WF21391
    • WF21165
    • WF21166
    • WF21168
    • WF21169
    • WF21170
    • WF21172
    • WF21173
    • WF21174
    • WF21175
    • WF21176
    • WF21177
    • WF21178
    • WF21179
    • WF21182
    • WF21183
    • WF21184
    • WF21185
    • WF21186
    • WF21187
    • WF21188
    • WF21189
    • WF21190
    • WF21192
    • WF21193
    • WF21194
    • WF21195
    • WF21196
    • WF21197
    • WF21198
    • WF21199
    • WF21200
    • WF21201
    • WF21202
    • WF21203
    • WF21204
    • WF21205
    • WF21206
    • WF21207
    • WF21208
    • WF21209
    • WF21210
    • WF21211
    • WF21212
    • WF21213
    • WF21214
    • WF21215
    • WF21217
    • WF21218
Amount recalled
212

Where it was sold

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:18 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.