Device product
ProCuity bed series, model number 3009, item number: 3009PX-LE-400.
Z-0427-2024
Product summary
- Event
- Event 93317
- Status
- Ongoing
- Classification
- Class II
- Quantity
- Unavailable
- Official record key
device-enforcement:Z-0427-2024
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): 07613327541182. Serial numbers: 2105002838 , 2105002832 , 2202000312 , 2202000286 , 2202000278 , 2202000180 , 2106002241 , 2106001240 , 2107001002 , 2203001053 , 2203001898 , 2112001135 , 2211002054 , 2105002782 , 2210002902 , 2210002890 , 2210002876 , 2210002858 , 2210002848 , 2111001420 , 2206001182
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.