Recall Z-0941-2015 ยท GEH Unit, Cryosurgical, Accessories
CSA Medical
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 cryosur
| Date | Jan 7, 2015 (initiated Nov 10, 2014) |
| Status | Terminated |
| Reason | An increase in complaint trending for a loss of audible sound associated with the timer has been observed. |
| Root cause | 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 | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K133258 | TRUFREEZE SYSTEM CSA Medical, Inc., Jun 19, 2014 |