Device product

CSA Medical truFreeze Console- Cryosurgical Unit Cryogenic Surgical Device Model: CC3-01

Z-1513-2015

March 25, 2015

Class II

Product summary

Firm: CSA Medical
Event: Event 70851
Status: Terminated
Classification: Class II
Quantity: 82 units
Official record key: device-enforcement:Z-1513-2015

Official wording

Reason: TruFreeze Console caused a higher rate of liquid nitrogen (cryogen) to be delivered and may cause: stricture,scarring, bradycardia, or pneumothorax

Code information: Serial Numbers: 01-00106 through 01-00201

Distribution pattern: Nationwide

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

TruFreeze Console caused a higher rate of liquid nitrogen (cryogen) to be delivered and may cause: stricture,scarring, bradycardia, or pneumothorax