Recall Z-0941-2015— CSA Medical
Class II · Terminated
Class II FDA medical device recall by CSA Medical, initiated 2014-11-10, terminated 2015-03-25. It names one FDA 510(k) clearance: K133258. 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.. Reason: An increase in complaint trending for a loss of audible sound associated with the timer has been observed..
- Recalling firm
- CSA Medical
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-11-10
- Terminated
- 2015-03-25
- Firm location
- Lexington, MA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product 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.
Reason for recall
An increase in complaint trending for a loss of audible sound associated with the timer has been observed.
Data sourced from openFDA. This site is unofficial and independent of the FDA.