Device product
ProCuity bed series, model number 3009, item number: 3009PX-L-200
Z-0426-2024
Product summary
- Event
- Event 93317
- Status
- Ongoing
- Classification
- Class II
- Quantity
- Unavailable
- Official record key
device-enforcement:Z-0426-2024
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): 07613327541199 Serial numbers: 2211000305 , 2112000828 , 2109001676 , 2109001666 , 2209002657 , 2208001565 , 2208001555 , 2208001541 , 2203002178 , 2203002161 , 2203002159 , 2203002157 , 2106000232 , 2106000210
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.