Merge Healthcare, Inc. recalls Schiller AG ISA CO2 Sensor (AKA: PhaseIn Unit), Merge Part Number HW-HEMO-00001. The PhaseIn Unit is an optional access…

Recall date

March 30, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1923-2017

FDA classification

Class II

Brand / firm

Merge Healthcare, Inc.

Sold / distributed

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.

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What 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.