CSA Medical truFreeze System; Model: CC3-01, a cryogenic surgical device ***The involved units are those with the newest version of a panel PC referred to as POC-127. These panels are identified by serial number. *** The truFreeze is intended for cryogenic destruction of tissue requiring either active or passive venting during surgical procedures. The truFreeze is indicated for use as a cryosurgical tool in the fields of dermatology, gynecology, and general surgery, to ablate benign and malignant lesions.
FDA Recall Z-0941-2015 · Posted 2015-01-07
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Recalling FirmCSA Medical
Recall StatusTerminated
Product CodeGEH
Date Initiated2014-11-10
Date Terminated2015-03-25
Product Quantity46
Reason for Recall
An increase in complaint trending for a loss of audible sound associated with the timer has been observed.
Firm Action
The firm, CSA Medical, sent a letter to its consignees 11/14/2014, via Fedex overnight . The letter explains the event and asks consignees to us a verbal call of time during the cryogen spray period until the root cause is determined and a permanent correction is implemented. Consignees are also asked to complete an acknowledgment form and return it to CSA Medical via, fax, email, telephone, etc.
Root Cause
Software design
Distribution Pattern
US Distribution to states of: AR, CA, CO, CT, DC, FL, GA, IL, IN, LA, MA, MD, MI, NC, NJ, NY, OK, PA, RI, SC, TN, TX, UT, VA, and WV.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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