Recall Z-1513-2015 ยท GEH Unit, Cryosurgical, Accessories
CSA Medical
CSA Medical truFreeze Console- Cryosurgical Unit Cryogenic Surgical Device Model: CC3-01
| Date | Apr 23, 2015 (initiated Mar 25, 2015) |
| Status | Terminated |
| Reason | TruFreeze Console caused a higher rate of liquid nitrogen (cryogen) to be delivered and may cause: stricture,scarring, bradycardia, or pneumothorax |
| Root cause | 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. Additi |
| Quantity | 82 units |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K143625 | truFreeze System CSA Medical, Inc., Jan 15, 2015 |