Device product
C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
Z-0613-2020
Product summary
- Event
- Event 84216
- Status
- Terminated
- Classification
- Class II
- Quantity
- 820
- Official record key
device-enforcement:Z-0613-2020
Official wording
Reason: The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operator s manual states 30 minutes for the minimum Dry Time for the 36 kHz Sterilization Tray and 36 kHz Components but 40 minutes is required for complete drying.
Code information: US Ops Manual P/N 60905769
Distribution pattern: US: AL AR AZ CA CO CT FL GA IA ID IL IN KS KY LA MA MD MI MN MO MS NC NE NJ NY OH OK OR PA SC TN UT VA WA WI WV International: SG MX CA JP AU CO TH HK
Derived failure modes
-
Unknown
The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operator s manual states 30 minutes for the minimum Dry Time for the 36 kHz Sterilization Tray and 36 kHz Components but 40 minutes is required for complete drying.