FDAFDA · Food and drugs·Recall number Z-1923-2017
Schiller AG ISA CO2 Sensor (AKA: PhaseIn 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.
Published May 10, 2017 · Recall initiated: March 30, 2015
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Telephone
Recall details
- Manufacturer
- Merge Healthcare, Inc.
- Distributor
- US Distribution was made to medical facilities located in AL, FL, ID, LA, MO, NC, OK, SC, TX, and UT. There was government distribution and no foreign/military distribution.
- Lot
- ISA CO2 Sensor serial numbers: 107349, 107357, 107358, 107363, 107370, 107377, 107390, 107407, 107435, 107476, 107509, 107510, 107556, 107659, 107700, 107707, 107768, 107776, 107831, 107832, 107836, 107839, and 107841.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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