Z-0941-2015Class II

CSA Medical truFreeze System; Model: CC3-01, a cryogenic surgical device ***The involved units are those with...

Name: Z-0941-2015 CSA Medical truFreeze System; Model: CC3-01, a cryogenic surgical device ***The involved units are those with...
Creator: CSA Medical
Published: 2014-11-10
License: https://open.fda.gov/license/

CSA Medical / initiated 2014-11-10 / Terminated / root cause: software

FDA source

CSA Medical began a recall of 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... on 2014-11-10. FDA classified it as Class II and gives the reason as "An increase in complaint trending for a loss of audible sound associated with the timer has been observed". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0941-2015
Classification: Class II
Status: Terminated
Initiated: 2014-11-10
Posted: 2015-01-07
Terminated: 2015-03-25
Recalling firm: CSA Medical
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.
Product code: GEH Unit, Cryosurgical, Accessories
Reason for recall: An increase in complaint trending for a loss of audible sound associated with the timer has been observed.
Root cause tag: software
FDA 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 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0941-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0941-2015	Class II	Terminated	Voluntary: Firm initiated	2015-01-14	2015-01-07

Product code GEH

K133258Class IITrufreeze SystemCSA Medical, Inc. / cleared 2014-06-19

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)