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Recall Observatory FDA recall evidence

Device 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.

Z-2622-2023

August 01, 2023

Class II

Product summary

Firm
Avanos Medical, Inc.
Event
Event 92852
Status
Completed
Classification
Class II
Quantity
24 units
Official record key
device-enforcement:Z-2622-2023

Official wording

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

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

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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

Field note

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