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U.S. Department of Health and Human Services

Class 2 Device Recall CSA Medical truFreeze Console

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  Class 2 Device Recall CSA Medical truFreeze Console see related information
Date Initiated by Firm March 25, 2015
Date Posted April 23, 2015
Recall Status1 Terminated 3 on August 21, 2015
Recall Number Z-1513-2015
Recall Event ID 70851
510(K)Number K143625  
Product Classification Unit, cryosurgical, accessories - Product Code GEH
Product CSA Medical truFreeze Console- Cryosurgical Unit Cryogenic Surgical Device
Model: CC3-01
Code Information Serial Numbers:  01-00106 through 01-00201
Recalling Firm/
Manufacturer		 CSA Medical
91 Hartwell Ave
Lexington MA 02421-3137
For Additional Information Contact
781-538-4720
Manufacturer Reason
for Recall		 TruFreeze Console caused a higher rate of liquid nitrogen (cryogen) to be delivered and may cause: stricture,scarring, bradycardia, or pneumothorax
FDA Determined
Cause 2		 Software design
Action CSA Medical issued letter dated 3/25/15 advising users of the problem. Users provided with: The mitigations available to the active venting procedures coupled with the extremely unlikely probability of injury, rare risk, thus allowing the physician to continue with active venting procedures. In regards a passive venting procedure may not have sufficient mitigation to allow the physician to identify the potential hazard with sufficient time to preclude a potential for injury. Therefore, passive users will be instructed not to use the system until a software improvement is put into place. Additionally, no catheters or consoles will be shipped to passive venting users of truFreeze. A response form to be signed and returned confirming receipt of the notification.Questions contact: Stephen Mascioli, MD 781-538-4755 smascioli@csamedical.com.
Quantity in Commerce 82 units
Distribution Nationwide
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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