medical Class II Updated 2023-09-27

Avanos Medical, Inc. recalls COOLIEF RF Generator is an 80-watt Radio-Frequency (RF) Gene

Recalled Product

COOLIEF RF Generator is an 80-watt Radio-Frequency (RF) Generator with four independent RF channels, allowing all RF channels to be activated individually or altogether. The system is controlled via a touch screen interface display that includes user controls, alarm messages, and on-screen selection of lesioning modalities.


Hazard / Issue

Avanos has received an increase in complaints from customers for COOLIEF RF Generators producing F100 and F101 faults.

Issued by

FDA

Affected States: AZ, CA, GA, IA, IN, KS, LA, MN, NC, NM, NY, OH, OR, TX, VA, VT
Lot/Code Info: STZ22277-006, STZ22277-007, STZ22277-008, STZ22277-009, STZ22277-010, STZ22277-011, STZ22277-012, STZ22277-013, STZ22277-014, STZ22277-015, STZ22277-016, STZ22277-017, STZ22277-018, STZ22277-019, STZ22277-020, STZ22277-021, STZ22277-022, STZ22277-023, STZ22277-024, STZ22277-025, STZ22277-026, STZ22277-027, STZ22277-028, STZ22277-029, STZ22318-001
View official government recall

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