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Terminated

RP500e Handheld Barcode Scanner, Zebra Model: DS4308 - HC0062BZZWW, Siemens Material Number (SMN) 11416778

FDA Recall Z-2432-2020 · Posted None

Recalling FirmSiemens Healthcare Diagnostics Inc
Recall StatusTerminated
Product CodeCHL
Date Initiated2020-05-27
Date Terminated2021-01-12
Product Quantity436

Reason for Recall

The scanner is not confirming the integrity of read barcode data using the check-digit when reading Code 39 barcodes.

Firm Action

On May 27, 2020, the firm notified customers via Urgent Field Safety Notice letters. Product was distributed to foreign customers only. Customers were instructed to complete and return the included customer response form. Customers whose systems are not configured to use code 39 with check-digit need take no further action. However, for customers whose systems are configured to use code 39 with check-digit, the customer notice provided two workaround options: 1) Use the integrated on-board barcode scanner, or 2) Re-configure the handheld barcode scanner following the instructions in the letter. If you have any questions, please contact your Siemens Customer Care Center or your local Siemens technical support representative

Root Cause

Software design

Distribution Pattern

Foreign distribution only.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K192240RAPIDPoint 500e Blood Gas SystemSiemens Healthcare Diagnostics, Inc. · 2020-03-27

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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