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Recall Observatory FDA recall evidence

Device product

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

Z-2432-2020

May 27, 2020

Class II

Product summary

Firm
Siemens Healthcare Diagnostics Inc
Event
Event 85750
Status
Terminated
Classification
Class II
Quantity
436
Official record key
device-enforcement:Z-2432-2020

Official wording

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

Code information: All units

Distribution pattern: Foreign distribution only.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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