Schiller AG ISA CO2 Sensor — Class II medical device recall Z-1923-2017
Terminated recall by Merge Healthcare, Inc., reported 2017-05-10, distributed in AL, FL, ID, LA, MO, NC, OK, SC…. The units may display the alarm "sampling line clogged" after the flow zeroing procedure that is conducted aut
| Recall number | Z-1923-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Merge Healthcare, Inc., Hartland, WI, United States |
| Recall initiated | 2015-03-30 |
| Classified | 2017-05-02 |
| Reported by FDA | 2017-05-10 |
| Terminated | 2017-05-05 |
| Distributed | AL, FL, ID, LA, MO, NC, OK, SC, TX, UT |
| Quantity | 23 sensors |
| Serial numbers | 107349, 107357, 107358, 107363, 107370, 107377, 107390, 107407, 107435, 107476, 107509, 107510, 107556, 107659, 107700, 107707, 107768, 107776, 107831, 107832, 107836, 107839, 107841 |
| Model numbers | HW-HEMO-00001 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1923-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.