Recall Z-2747-2020— Siemens Healthcare Diagnostics, Inc.

Name: FDA recall Z-2747-2020
Creator: U.S. Food and Drug Administration
Published: 2020-06-30

Class II · Terminated

Class II FDA medical device recall by Siemens Healthcare Diagnostics, Inc., initiated 2020-06-30, terminated 2020-11-17. It names one FDA 510(k) clearance: K071466. Product: DCA Vantage Handheld Barcode Scanner - Zebra Model - Model # DS4308 - HC0015BZZWW external accessory to DCA Vantage Analyzer US. 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: Siemens Healthcare Diagnostics, Inc.
Classification: Class II
Status: Terminated
Initiated: 2020-06-30
Terminated: 2020-11-17
Firm location: Newark, DE, United States

510(k) clearances named in this recall

1 on FDA's record

K071466 — DCA VANTAGE, MODEL 5075Siemens Medical Solutions Diagnostics·cleared 2007-10-09

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.