Home / Recalls / Medical Devices
Abbott Laboratories, Inc. recalls CardioMEMS HF System Hospital and Patient Electronics Units: (a) Patient Electronics System, Model CM1100 (b) Hospital
Recalled August 1, 2018 · FDA recall Z-2522-2018 · Abbott Laboratories
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. · FDA Class II
Units
2521 units
Sold at
US, Canada, Netherlands, Germany, Great Britain, France, Ireland, Belgium
Description
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.
Product
CardioMEMS HF System Hospital and Patient Electronics Units: (a) Patient Electronics System, Model CM1100 (b) Hospital Electronics System, Model CM3000
Manufacturer(s)
Abbott Laboratories, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →