Device product
ProCuity bed series, model number 3009, item number: 3009PX-LE-450.
Z-0428-2024
Product summary
- Event
- Event 93317
- Status
- Ongoing
- Classification
- Class II
- Quantity
- Unavailable
- Official record key
device-enforcement:Z-0428-2024
Official wording
Reason: Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock.
Code information: UDI-DI (GTIN): 07613327541175. Serial numbers: 2109000993 , 2208000147 , 2209000850 , 2211002051 , 2202000910 , 2209000408 , 2205000619 , 2205000615 , 2205000612 , 2205000587 , 2205000746 , 2205000745 , 2205000739 , 2109000135 , 2109000124
Distribution pattern: Distribution US Nationwide including Puerto Rico, Australia, Canada, Chile, China, Mexico, Poland, Spain and Switzerland.
Derived failure modes
-
Unknown
Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock.