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U.S. Department of Health and Human Services

Class 2 Device Recall CSA Medical trufreeze

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  Class 2 Device Recall CSA Medical trufreeze see related information
Date Initiated by Firm November 10, 2014
Date Posted January 07, 2015
Recall Status1 Terminated 3 on March 25, 2015
Recall Number Z-0941-2015
Recall Event ID 69806
510(K)Number K133258  
Product Classification Unit, cryosurgical, accessories - Product Code GEH
Product 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.
Code Information Console SN/Lot NO: 01-00109, 01-00112, 01-00113, 01-00115, 01-00120, 01-00121, 01-00122, 01-00123, 01-00132, 01-00133, 01-00135, 01-00137, 01-00142, 01-00148, 01-00156, 01-00159, 01-00160, 01-00161, 01-00162,  01-00163, 01-00165, 01-00166, 01-00168, 01-00169, 01-00170, 01-00171, 01-00172, 01-00173, 01-00174, 01-00175, 01-00176, 01-00177, 01-00178, 01-00179, 01-00180, 01-00181, 01-00182, 01-00183, 01-00185, 01-00186,  01-00187, 01-00188, 01-00189, 01-00190, 01-00191, 01-00192
Recalling Firm/
Manufacturer		 CSA Medical
91 Hartwell Ave
Lexington MA 02421-3137
For Additional Information Contact Ellen E. Sheets, MD
781-538-4737
Manufacturer Reason
for Recall		 An increase in complaint trending for a loss of audible sound associated with the timer has been observed.
FDA Determined
Cause 2		 Software design
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.
Quantity in Commerce 46
Distribution 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = GEH and Original Applicant = CSA MEDICAL, INC.
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