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
WF21150WF21159WF21163WF21164WF21167WF21171WF21371WF21372WF21377WF21378WF21158WF21391WF21165WF21166WF21168WF21169WF21170WF21172WF21173WF21174WF21175WF21176WF21177WF21178WF21179WF21182WF21183WF21184WF21185WF21186WF21187WF21188WF21189WF21190WF21192WF21193WF21194WF21195WF21196WF21197WF21198WF21199WF21200WF21201WF21202WF21203WF21204WF21205WF21206WF21207WF21208WF21209WF21210WF21211WF21212WF21213WF21214WF21215WF21217WF21218
- 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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