Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1923-2017 — 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.

U.S. FDA — Device Enforcement · United States · 2015-03-30 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1923-2017
Date of alert: 2015-03-30
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Merge Healthcare, Inc.
Product category: device
Product type: Devices

Reported risk: 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.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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Recall Z-1923-2017 — 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.

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