Device product
ProCurity bed series, model number 3009, item number: 3009PX-ZMX-600.
Z-0435-2024
Product summary
- Event
- Event 93317
- Status
- Ongoing
- Classification
- Class II
- Quantity
- Unavailable
- Official record key
device-enforcement:Z-0435-2024
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): 07613327541328. Serial numbers: 2209001834, 2209001941 , 2209001939 , 2211002329 , 2211002319 , 2211000556 , 2205000776 , 2106000019 , 2202002062 , 2106001528 , 2106001515 , 2209001539 , 2203000249 , 2106002482 , 2202001091 , 2203000298 , 2203000098 , 2108000232 , 2208000679 , 2110000200 , 2106002061 , 2106002051 , 2106001697 , 2211004469 , 2211004828 , 2206001229 , 2206001234 , 2211004824 , 2106001589 , 2209002761 , 2209002730 , 2209002674 , 2111000113 , 2111000111 , 2208001113
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.