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Terminated

Cool-tip RF Generator, for use in percutaneous, laparoscopic, intraoperative coagulation and ablation of tissue.

FDA Recall Z-0859-06 · Posted 2006-05-10

Recalling FirmCovidien LP
Recall StatusTerminated
Product CodeGEI
Date Initiated2006-04-21
Date Terminated2009-02-26
Product Quantity137 units

Reason for Recall

Electrosurgical ablation device may experience loss of power during use, when used with Cool-tip Switching controller in ablation mode.

Firm Action

Consignees were notified by telephone followed by a fax on 04/21/2006.

Root Cause

Other

Distribution Pattern

Nationwide. AZ, CA, CO, CT, FL, GA, IL, MA, MI, MN, MO, MS, NC, NE, NJ, OH, OK, PA, TX, VA. Foreign distribution to Argentina, Canada, Chile, Costa Rica, France, Greece, Israel, Peru, Singapore.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K984552COOL-TIP RF SYSTEMRadionics, Inc. · 1999-03-05

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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