Recall Z-2522-2018— Abbott Laboratories, Inc.
Class II · Terminated
Class II FDA medical device recall by Abbott Laboratories, Inc., initiated 2018-06-14, terminated 2021-09-08. FDA's recall record names no specific 510(k) clearance for this event. Product: CardioMEMS HF System Hospital and Patient Electronics Units: (a) Patient Electronics System, Model CM1100 (b) Hospital Electronics System, Model CM3000. Reason: 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..
- Recalling firm
- Abbott Laboratories, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-06-14
- Terminated
- 2021-09-08
- Firm location
- Atlanta, GA, United States
Product description
CardioMEMS HF System Hospital and Patient Electronics Units: (a) Patient Electronics System, Model CM1100 (b) Hospital Electronics System, Model CM3000
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.