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Recall Observatory FDA recall evidence

Device product

DCA Vantage Handheld Barcode Scanner - Zebra Model - Model # DS4308 - HC0015BZZWW external accessory to DCA Vantage Analyzer US

Z-2747-2020

June 30, 2020

Class II

Product summary

Firm
Siemens Healthcare Diagnostics, Inc.
Event
Event 85980
Status
Terminated
Classification
Class II
Quantity
1800 units
Official record key
device-enforcement:Z-2747-2020

Official wording

Reason: If DCA Vantage Analyzer is configured to run Code 39 with check digit, the scanner is not confirming the integrity of read barcode data using the check digit. Also, if DCA Vantage Analyzer is configured to run Code 39 with check digit and an operator erroneously scans a Code 39 barcode without a check digit, the scanner incorrectly sends the code and the last character is removed.

Code information: DCA Vantage Handheld Barcode Scanner #11306432 Model: DS4308 - HC0015BZZWW

Distribution pattern: Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    If DCA Vantage Analyzer is configured to run Code 39 with check digit, the scanner is not confirming the integrity of read barcode data using the check digit. Also, if DCA Vantage Analyzer is configured to run Code 39 with check digit and an operator erroneously scans a Code 39 barcode without a check digit, the scanner incorrectly sends the code and the last character is removed.