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

What’s New

FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:  https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/exemptions-variances-and-alternate-forms-adverse-event-reporting-medical-devices

Corporate Office

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