Z-1923-2017Class II

Schiller AG ISA CO2 Sensor (AKA: PhaseIn Unit), Merge Part Number HW-HEMO-00001. The PhaseIn Unit is an...

Name: Z-1923-2017 Schiller AG ISA CO2 Sensor (AKA: PhaseIn Unit), Merge Part Number HW-HEMO-00001. The PhaseIn Unit is an...
Creator: Merge Healthcare, Inc.
Published: 2015-03-30
License: https://open.fda.gov/license/

Merge Healthcare Incorporated / initiated 2015-03-30 / Terminated

FDA source

Merge Healthcare, Inc. began a recall of 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... on 2015-03-30. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1923-2017
Classification: Class II
Status: Terminated
Initiated: 2015-03-30
Posted: 2017-05-02
Terminated: 2017-05-05
Recalling firm: Merge Healthcare Incorporated
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.
Product code: DQK Computer, Diagnostic, Programmable
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.
FDA root cause: Unknown/Undetermined by firm
Action: The recall was initiated by telephone on March 30, 2015. Follow-up phone calls were made July 6, 2015. The firm was unable to provide a telephone script. The recalling firm also issued letters dated March 28, 2016, via email on April 6, 2016, dated July 11, 2016. The letters contained the same content, notified the customer of the issue, and informed them a fix was available. The notification instructs the customer to pass the information onto all other users, as well as any downstream customers if it was further distributed. The notification also informs the customer their response is required using the enclosed form and the return addressed envelope. The response form asks, in part, if they have the affected ISA CO2 sensors at their facility and are they interested in accepting the fix. If they decline the fix, they are asked to provide the reason why. For further questions, please call (877) 741-5369.
Quantity in commerce: 23 sensors (PhaseIn Units)
Distribution: 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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1923-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1923-2017	Class II	Terminated	Voluntary: Firm initiated	2017-05-10	2017-05-02

Product code DQK

K082421Class IIHeartsuite Hemodynamics 7.10Emageon, Inc. / cleared 2008-12-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)