Recall – Barcode data not read correctly

Company: Siemens Healthcare Diagnostics Inc
Date of Enforcement Report: 7/1/2020
Class II

PRODUCT

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

Recall Number: Z-2432-2020

REASON

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

RECALLING FIRM/MANUFACTURER

Siemens Healthcare Diagnostics Inc on 5/27/2020. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

436

DISTRIBUTION

International

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.

Corporate Office

15148 Springview St.
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN, TX) and Canada.