FDA-Device2018-08-01Class II
CardioMEMS HF System Hospital and Patient Electronics Units: (a) Patient Electronics System, Model CM1100 (b) Hospital Electronics System, Model CM3000
Abbott Laboratories, Inc.
Hazard
Abbott is advising customers that a small number of CardioMEMS(R) Hospital Electronics Systems (Model CM3000) and Patient Electronics Systems (Model CM1100) may deliver a system error, known as Error 5. While this error message is intended to present if the electronics system exceeds a certain temperature, these units may deliver a false Error 5 message due to an incorrectly configured component within the device electronics.
Sold states
US, Canada, Netherlands, Germany, Great Britain, France, Ireland, Belgium
Affected count
2521 units
Manufactured in
387 Technology Cir Nw Ste 500, N/A, Atlanta, GA, United States
Products
CardioMEMS HF System Hospital and Patient Electronics Units: (a) Patient Electronics System, Model CM1100 (b) Hospital Electronics System, Model CM3000
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2522-2018Don't want to check this manually?
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