Z-2622-2023 Class II
Recall Details
- Product Type
- Devices
- Report Date
- September 27, 2023
- Initiation Date
- August 1, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 24 units
Product Description
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.
Reason for Recall
Avanos has received an increase in complaints from customers for COOLIEF RF Generators producing F100 and F101 faults.
Distribution Pattern
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
Code Information
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