Merge Healthcare, Inc.: Medical Device Recall in 2017 - (Recall #: Z-1923-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: March 30, 2015

Date Posted: May 10, 2017

Recall Number: Z-1923-2017

Event ID: 76946

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.

Status: Terminated

Product Quantity: 23 sensors (PhaseIn Units)

Code Information:

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.

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated