Siemens Dimension Vista 500 and 1500 Systems Recalled for Flex Assignment Error
Siemens is recalling Dimension Vista 500 and 1500 systems with software version 3.5.1 or lower because the system may assign the wrong Flex cartridge to user-defined methods.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk of harm (incorrect test results) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling the User Defined Method Flex Assignment feature for the Siemens Dimension Vista 500 and Dimension Vista 1500 systems. The recall affects systems running software version 3.5.1 or lower. A total of 2,038 units are involved in this recall.
The recall is due to a software defect where the system may incorrectly assign a User Defined Method Flex to a different Flex cartridge currently in inventory. This error can cause the system to use the incorrect Flex cartridge to process the user-defined method, potentially leading to inaccurate test results. The affected material numbers are 10284473, 1048824, 10444801, and 10444802.
The recalled products were distributed nationwide in the United States, including Puerto Rico. Healthcare facilities using these systems should contact Siemens Healthcare Diagnostics for instructions on how to resolve the issue. Users should verify their software version and contact the manufacturer if they are using the affected software versions.
The recalled product
- 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…
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 2,038
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Material numbers 10284473
- 10488224
- 10444801
- and 10444802.
Distribution
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