Recall Z-2432-2020— Siemens Healthcare Diagnostics Inc

Name: FDA recall Z-2432-2020
Creator: U.S. Food and Drug Administration
Published: 2020-05-27

Class II · Terminated

Class II FDA medical device recall by Siemens Healthcare Diagnostics Inc, initiated 2020-05-27, terminated 2021-01-12. It names one FDA 510(k) clearance: K192240. Product: RP500e Handheld Barcode Scanner, Zebra Model: DS4308 - HC0062BZZWW, Siemens Material Number (SMN) 11416778. Reason: The scanner is not confirming the integrity of read barcode data using the check-digit when reading Code 39 barcodes..

Recalling firm: Siemens Healthcare Diagnostics Inc
Classification: Class II
Status: Terminated
Initiated: 2020-05-27
Terminated: 2021-01-12
Firm location: Norwood, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K192240 — RAPIDPoint 500e Blood Gas SystemSiemens Healthcare Diagnostics, Inc.·cleared 2020-03-27

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.