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

Remote Webmeeting Assessments

SoftwareCPR can provide remote offsite assessments to support virtual offices.  Our consultants can utilize webmeeting tools to walk your teams through assessments such as:

  • 62304 compliance
  • Regulatory submission pre-review
  • Software risk analysis
  • Cybersecurity process and validation
  • Overall ISO 14971 risk management
  • Overview of software regulation with John Murray

Email office@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) and Italy.