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.
Reported: May 10, 2017 Initiated: March 30, 2015 #Z-1923-2017
Product Description
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.
Reason for Recall
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.
Details
- Recalling Firm
- Merge Healthcare, Inc.
- Units Affected
- 23 sensors (PhaseIn Units)
- Distribution
- 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.
- Location
- Hartland, WI
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Merge Healthcare, Inc.. Units affected: 23 sensors (PhaseIn Units).
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 10, 2017. Severity: Moderate. Recall number: Z-1923-2017.
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