Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Schiller AG ISA CO2 Sensor (AKA: PhaseIn Unit) Recalled by Merge Healthcare, Inc. Due to The units may display the alarm "sampling line...

Date: March 30, 2015
Company: Merge Healthcare, Inc.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Merge Healthcare, Inc. directly.

Affected Products

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.

Quantity: 23 sensors (PhaseIn Units)

Why Was This 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.

Where Was This Sold?

This product was distributed to 10 states: AL, FL, ID, LA, MO, NC, OK, SC, TX, UT

Affected (10 states)Not affected

About Merge Healthcare, Inc.

Merge Healthcare, Inc. has 93 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report