CLASS II Device recall · Reported 10 May 2017 · FDA Enforcement Report

Schiller AG ISA CO2 Sensor (AKA: PhaseIn Unit), Merge recalled

Merge Healthcare is recalling Schiller AG ISA CO2 Sensor (AKA: PhaseIn Unit), Merge, distributed in 10 states. The recall was initiated on 30 Mar 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesISA 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.

Quantity recalled23 sensors (PhaseIn Units)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1923-2017
FDA event ID: 76946
Recalling firm: Merge Healthcare, Hartland, WI
Classification: Class II
Status: Terminated
Recall initiated: 30 Mar 2015
FDA classified: 2 May 2017
Reported: 10 May 2017
Type: Voluntary: Firm initiated
Customers notified by: Telephone
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

30 Mar 2015	Recall initiated by company
2 May 2017	Classified by FDA	+764 days
10 May 2017	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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.

Where it was 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.

Alabama Florida Idaho Louisiana Missouri North Carolina Oklahoma South Carolina Texas Utah

Questions about this recall

Why was it recalled?

Which lots are affected?

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.

Where was it sold?

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.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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