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.
Recall
- Recall Number
- Z-0941-2015
- Event Number
- 69806
- FEI Number
- 3010140265
- Product Code
- GEH
- Status
- Terminated
- Root Cause
- Software design
- Initiated
- November 10, 2014
- Posted
- January 7, 2015
- Terminated
- March 25, 2015
- Address
- CSA Medical 91 Hartwell Ave, Lexington, MA, 02421-3137
Description
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.
An increase in complaint trending for a loss of audible sound associated with the timer has been observed.
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.
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.
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