Recall Z-1923-2017— Merge Healthcare, Inc.

Name: FDA recall Z-1923-2017
Creator: U.S. Food and Drug Administration
Published: 2015-03-30

Class II · Terminated

Class II FDA medical device recall by Merge Healthcare, Inc., initiated 2015-03-30, terminated 2017-05-05. It names one FDA 510(k) clearance: K082421. Product: 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: 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..

Recalling firm: Merge Healthcare, Inc.
Classification: Class II
Status: Terminated
Initiated: 2015-03-30
Terminated: 2017-05-05
Firm location: Hartland, WI, United States

510(k) clearances named in this recall

1 on FDA's record

K082421 — HEARTSUITE HEMODYNAMICS 7.10Emageon, Inc.·cleared 2008-12-17

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.