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CHANGE HEALTHCARE CANADA COMPANY: Change Healthcare Cardiology Hemo. Versions 14.2, 14.1.1...

A potential issue has been identified in Change Healthcare Cardiology Hemo where incorrect data entry can lead to inaccurate hemodynamic calculations, potentially resulting in misdiagnosis and inappropriate treatment. This issue occurs when the unit of measurement (UOM) for hemoglobin is configured in a way that differs from the users understanding.

Moderate

FDAAug 21, 2024Nationwide• CHANGE HEALTHCARE CANADA COMPANY

CHANGE HEALTHCARE CANADA COMPANY: McKesson Cardiology Hemo. Versions 13.0, 13.1.1, 13.1.2, ...

Moderate

FDA

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CHANGE HEALTHCARE CANADA COMPANY: Change Healthcare Cardiology Hemo. Versions 14.2, 14.1.1...

CHANGE HEALTHCARE CANADA COMPANY: McKesson Cardiology Hemo. Versions 13.0, 13.1.1, 13.1.2, ...

Ceremonial Cacao Paste (Inner Waymark) – Elevated Lead (2024)

CHANGE HEALTHCARE CANADA COMPANY: Horizon Cardiology Hemo. Version 12.2.

Medtronic Neuromodulation: Vanta Implantable Neurostimulator (INS), Model 977006

Ossur H F Grjothals 5 Reykjavik Iceland: Miami J Select Collar, Catalog: MJS-101; Miami J Select C...

Merit Medical Systems, Inc.: DiamondTOUCH Digital Inflation Device, REF: IN9135/A, IN9...

Merit Medical Systems, Inc.: Blue Diamond Digital Inflation Device, REF: IN7152/C, IN7...

Merit Medical Systems, Inc.: BlueFIRE Inflation Device, REF: IN10140

Merit Medical Systems, Inc.: MONARCH Inflation Device, REF: IN2430/B, IN2530/B, IN2130/B

Merit Medical Systems, Inc.: basixSKY Inflation Device, REF: SKY1802

Merit Medical Systems, Inc.: Custom Inflation Kit, REF: K05-00052M, K05-00053H, K05-00...

Merit Medical Systems, Inc.: basixTOUCH Inflation Device, REF: IN8140/A

Merit Medical Systems, Inc.: IntelliSystem Inflation Device, REF: IN1525/D

Merit Medical Systems, Inc.: StabiliT TOUCH Syringe, REF: IN8VCF/B

Ground Cinnamon (Gutierrez Distributors) – Elevated Lead (2024)

Roche Diagnostics Operations, Inc.: Creatine Kinase (CK) used on cobas c 311/501/502 and COBA...

Murata Vios, Inc.: Vios Monitoring System Bedside Monitor Model BSM2050

Alcon Research LLC: DAILIES TOTAL1, DAILIES TOTAL1 for Astigmatism, DAILIES T...

Fisher & Paykel Healthcare, Ltd. 15 Maurice Paykel Place East Tamaki Auckland New Zealand: PT301US Airvo 3 Respiratory Support Device with software ...