Recalls / —

—#181676

Product

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

FDA product code

CHL — Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph

Device class

Class 2

Medical specialty

Clinical Chemistry

510(k) numbers

K192240

Affected lot / code info

All units

Why it was recalled

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

Root cause (FDA determination)

Software design

Action the firm took

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

Recalling firm

Firm

Siemens Healthcare Diagnostics Inc

Address

2 Edgewater Dr, Norwood, Massachusetts 02062-4637

Distribution

Distribution pattern

Foreign distribution only.

Timeline

Recall initiated

2020-05-27

Terminated

2021-01-12

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #181676. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.