Device product
C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
Z-0617-2020
Product summary
- Event
- Event 84216
- Status
- Terminated
- Classification
- Class II
- Quantity
- 820
- Official record key
device-enforcement:Z-0617-2020
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 Operators 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: French OPS Manual P/N 60905770
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 Operators 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.