Device product
ProCuity bed series, model number 3009, item number: 3009PX-ZM-600.
Z-0433-2024
Product summary
- Event
- Event 93317
- Status
- Ongoing
- Classification
- Class II
- Quantity
- Unavailable
- Official record key
device-enforcement:Z-0433-2024
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): 07613327541311. Serial numbers: 2201000173, 2110001895, 2203001506, 2110000413, 2110000411, 2208002037, 2208002030, 2208002019& 2212000691
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.