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FDA (Device enforcement)Recalled 2023-08-01class ii

Avanos Medical, Inc.: 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 syst

Hazard

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

Details from the source

Reason for recall: Avanos has received an increase in complaints from customers for COOLIEF RF Generators producing F100 and F101 faults. Distribution: US Distribution to states of: AZ, CA, GA, IA, IN, KS, LA, MN, NC, NM, NY, OH, OR, TX, VA, VT, and OUS International distribution to country of: BRAZIL Quantity: 24 units 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

Source

Official record: FDA (Device enforcement)

Republished from the official source above; details can change — the source record controls.

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