Z-2432-2020Class II

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

Name: Z-2432-2020 RP500e Handheld Barcode Scanner, Zebra Model: DS4308 - HC0062BZZWW, Siemens Material Number (SMN) 11416778
Creator: Siemens Healthcare Diagnostics Inc
Published: 2020-05-27
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2020-05-27 / Terminated / root cause: software

FDA source

Siemens Healthcare Diagnostics Inc began a recall of RP500e Handheld Barcode Scanner, Zebra Model: DS4308 - HC0062BZZWW, Siemens Material Number (SMN) 11416778 on 2020-05-27. FDA classified it as Class II and gives the reason as "The scanner is not confirming the integrity of read barcode data using the check-digit when reading Code 39 barcodes". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2432-2020
Classification: Class II
Status: Terminated
Initiated: 2020-05-27
Posted: 2020-06-26
Terminated: 2021-01-12
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: RP500e Handheld Barcode Scanner, Zebra Model: DS4308 - HC0062BZZWW, Siemens Material Number (SMN) 11416778
Product code: CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Reason for recall: The scanner is not confirming the integrity of read barcode data using the check-digit when reading Code 39 barcodes.
Root cause tag: software
FDA root cause: Software design
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
Quantity in commerce: 436
Distribution: Foreign distribution only.
Product codes and lots: All units

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2432-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2432-2020	Class II	Terminated	Voluntary: Firm initiated	2020-07-01	2020-06-26

Product code CHL

K192240Class IIRAPIDPoint 500e Blood Gas SystemSiemens Healthcare Diagnostics, Inc. / cleared 2020-03-27

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)