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FDA Medical Device Recalls (openFDA)

Siemens Healthcare Diagnostics, Inc.: DCA Vantage Handheld Barcode Scanner - Zebra Model - Model # DS4308 - HC0015BZZWW external accessory to DCA Vantage Analyzer US

Recall number
Z-2747-2020
Recalling firm
Siemens Healthcare Diagnostics, Inc.
Product
DCA Vantage Handheld Barcode Scanner - Zebra Model - Model # DS4308 - HC0015BZZWW external accessory to DCA Vantage Analyzer US
Status
Terminated
Initiated
2020-06-30
Posted
not on file
Terminated
2020-11-17
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.
Root cause
Labeling design
Action
Siemens Healthcare Diagnostics issues a field safety notice date June 2020 to customers
Quantity
1800 units
Distribution
Nationwide
Lot, serial or model codes
DCA Vantage Handheld Barcode Scanner #11306432 Model: DS4308 - HC0015BZZWW
510(k) numbers
["K071466"]
PMA numbers
not on file
Product code
LCP
Firm FEI
2517506
Firm city
Newark
Firm state
DE
Firm country
not on file

Where this comes from

Register
FDA Medical Device Recalls (openFDA)
Publisher
U.S. Food and Drug Administration (openFDA)
File
device-recall-0001-of-0001.json.zip
sha256
b87518bfe2e8
Size
288210821 bytes
Published
2026-09-28
Read
2026-09-29T08:25:23.626Z
Source file
Source file retained · verify
Refresh due
2026-10-06

Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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