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Cardiomems hospital electronics system
Official notice
23 Feb 2023
An official Health Canada notice concerns Cardiomems hospital electronics system. The Cardiomems HF System is intended to operate at frequencies between 30 and 37.5 MHz. Abbott has found that a small number (less than 1%) of implanted Cardiomems PA sensors (model CM2000) have operated outside of this intended radiofrequency range at least once over the life of the implant when interrogated by Cardiomems patient or hospital systems (models CM1100 and CM3000). Operating frequency may be affected by atmospheric conditions, elevation, pulmonary artery (pa) pressure, and unique sensor and patient characteristics. Recall start date: February 7, 2023 Published 2023-02-23.
What to do now
Contact the manufacturer if you require additional information.
Recall number
72929
Official notice
2023-02-23
The hazard
The hazard
The Cardiomems HF System is intended to operate at frequencies between 30 and 37.5 MHz. Abbott has found that a small number (less than 1%) of implanted Cardiomems PA sensors (model CM2000) have operated outside of this intended radiofrequency range at least once over the life of the implant when interrogated by Cardiomems patient or hospital systems (models CM1100 and CM3000). Operating frequency may be affected by atmospheric conditions, elevation, pulmonary artery (pa) pressure, and unique sensor and patient characteristics. Recall start date: February 7, 2023
How to check if you're affected
How to check if you're affected
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Brand: Abbott Medical, Cardiomems Hospital Electronics System.
Source & status
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Recall details
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Documents, notices & source
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