Device product
User Defined Method Flex Assignment/Siemens Dimension Vista 500 or Dimension Vista 1500 System with software version 3.5.1 or lower User Defined Method Flex Assignment/Siemens Dimension Vista 500 or Dimension Vista 1500 System is an in vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluids.
Z-0851-2014
Product summary
- Event
- Event 66585
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2038
- Official record key
device-enforcement:Z-0851-2014
Official wording
Reason: When utilizing the Routine Inventory screen to enter a User Defined Method (EMPTY) Flex the system may assign the User Defined Method Flex to a different Flex that is currently in inventory on the system, and then use the incorrect Flex Cartridge to process the user defined method.
Code information: Material numbers 10284473, 10488224, 10444801, and 10444802.
Distribution pattern: USA (nationwide) Distribution including Puerto Rico.
Derived failure modes
-
Unknown
When utilizing the Routine Inventory screen to enter a User Defined Method (EMPTY) Flex the system may assign the User Defined Method Flex to a different Flex that is currently in inventory on the system, and then use the incorrect Flex Cartridge to process the user defined method.