Siemens DCA Vantage Barcode Scanner Recalled for Data Integrity Issues
Siemens Healthcare is recalling 1,800 DCA Vantage Handheld Barcode Scanners because they may fail to verify check digits or incorrectly process barcodes, potentially leading to data errors.
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 2/5 (Moderate).
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 data integrity errors rather than direct physical injury or high-risk pathogens, fitting the criteria for moderate severity where the risk is significant but not immediately life-threatening or associated with reported injuries.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 1,800 units of the DCA Vantage Handheld Barcode Scanner (Zebra Model # DS4308 - HC0015BZZWW). This device is an external accessory used with the DCA Vantage Analyzer US. The recall was initiated because the scanner may not correctly confirm the integrity of read barcode data when the analyzer is configured to run Code 39 with a check digit.
Additionally, if the analyzer is configured for Code 39 with a check digit and an operator scans a Code 39 barcode without a check digit, the scanner may incorrectly send the code and remove the last character. This defect could result in data integrity issues within the analyzer system.
The affected units were distributed nationwide. Users of the DCA Vantage Analyzer US should check their scanner model and contact Siemens Healthcare Diagnostics, Inc. for further instructions on the recall.
The recalled product
- Product
- DCA Vantage Handheld Barcode Scanner - Zebra Model - Model # DS4308 - HC0015BZZWW external accessory to DCA Vantage Analyzer US
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 1,800
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 (1)
- DCA Vantage Handheld Barcode Scanner #11306432 Model: DS4308 - HC0015BZZWW
Distribution
Distributed nationwide across the United States.
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