Recall – Bar-code scanner incorrectly accounts for check digit

Company: Siemens Healthcare Diagnostics, Inc.
Date of Enforcement Report: 8/12/2020
Class II

PRODUCT

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

Recall Number: Z-2747-2020

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.

RECALLING FIRM/MANUFACTURER

Siemens Healthcare Diagnostics, Inc. on 6/30/2020. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

1800 units

DISTRIBUTION

U.S. Nationwide

SoftwareCPR Training Courses:

IEC 62304 and other Emerging Standards Impacting Medical Device Software

Being Agile & Yet Compliant

ISO 14971 SaMD Risk Management

Software Risk Management

Medical Device Cybersecurity

Software Verification

IEC 62366 Usability Process and Documentation

Or just email training@softwarecpr.com for more info.

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