Reported May 10, 2017 · Terminated
Schiller AG ISA CO2 Sensor (AKA: PhaseIn Unit), Merge Part Number HW-HEMO-00001. The PhaseIn Unit is an optional…
Merge Healthcare, Inc.
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: Merge Healthcare, Inc. · 900 Walnut Ridge Dr · Hartland, WI · 53029-8347
Is this the product you have?
- Schiller AG ISA CO2 Sensor (AKAPhaseIn Unit), Merge Part Number HW-HEMO-00001. The PhaseIn Unit is an optional accessory (sold separately) to the Merge Hemo Patient Data Module (PDM). The PDM is a major component of the Merge Hemo system
- Lot codes and dates
- ISA CO2 Sensor serial numbers
107349107357107358107363107370107377107390107407107435107476107509107510107556107659107700107707107768107776107831107832107836107839and 107841
- ISA CO2 Sensor serial numbers
- Amount recalled
- 23 sensors (PhaseIn Units)
Where it was sold
Why it was recalled
The units may display the alarm "sampling line clogged" after the flow zeroing procedure that is conducted automatically 1 hour after start up. This could result in the potential of a small bias added to the CO2 measurement and affect the alarm notification.
This product could cause temporary or reversible health problems — stop using it.
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