Siemens Dimension Vista Systems Recalled for Software Processing Errors
Siemens is recalling Dimension Vista Systems due to software issues that may cause samples to stop processing or deliver incorrect reagents, leading to unexpected test results.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves software errors leading to incorrect test results, which is a significant quality issue but does not involve direct physical injury or death, fitting the Moderate severity criteria for low-risk contamination or labeling/processing errors.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 2,315 Dimension Vista Systems used with the Dimension Vista Intelligent Lab System software version 3.6.1. These in vitro diagnostic analyzers were distributed worldwide, including in the United States, Puerto Rico, and numerous international countries.
The recall is due to two software issues. First, samples may stop processing without notification. Second, a timing issue in the Vista 1500 model may cause the wrong reagent to be delivered or no reagent to be delivered at all. These issues may lead to unflagged, unexpectedly low results or results flagged with assay errors.
The affected units are identified by Siemens Material Numbers (SMN) 10284473, 10488224, 10444801, and 10444802. Users of these systems should contact Siemens Healthcare Diagnostics for further instructions on resolving the software issues.
The recalled product
- Product
- Siemens Healthcare Diagnostics Dimension Vista Systems, used with the Dimension Vista Intelligent Lab System software version 3.6.1. In vitro diagnostic analyzer.
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 2,315
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)
- Siemens Material Number (SMN): 10284473
- 10488224
- 10444801
- 10444802
Distribution
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