February 9, 2022
Company: Abiomed, Inc. Date of Enforcement Report: 2/9/2022 Class I PRODUCT OXY-1 System, Model Number 001-0500-001. Used during cardiopulmonary bypass. OXY-1 System consists of Console, Pump Drive, E Drive, and Pole Mount. The disposable Pump Lung Unit PLU part number 001-0400-100 is sold separately and is not part of this recall. Recall Number: Z-0550-2022 REASON...
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Company: Philips North America LLC Date of Enforcement Report: 2/9/2022 Class II PRODUCT A software tool intended for use by trained medical staff providing supplemental remote support to bedside care teams in the management and care of in-hospital patients. eCareManager version 4.2.1, eCareManager version 4.3.2, eCareManager version 4.3.3, eCareManager version 4.5.1, eCareManager version 4.5.2, eCareManager...
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Company: Siemens Medical Solutions USA, Inc. Date of Enforcement Report: 2/9/2022 Class II PRODUCT ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B Recall Number: Z-0547-2022 REASON Due to a calculation error in the measurement when using 2D trace (manual trace) tool. The trace circumference value is overestimated and may potentially result in misdiagnosis of...
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