Siemens RP500e Handheld Barcode Scanner Recalled for Data Integrity Failure
Siemens Healthcare Diagnostics Inc. is recalling 436 RP500e Handheld Barcode Scanners because they fail to verify Code 39 barcode data integrity using check-digits.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically involves a temporary or medically reversible adverse health consequence. The defect is a data integrity issue (failure to verify check-digits) rather than a direct physical hazard like fire or shock, and no injuries or illnesses are reported in the source text.
Plain-English summary
Siemens Healthcare Diagnostics Inc. is recalling 436 units of the RP500e Handheld Barcode Scanner (Zebra Model: DS4308 - HC0062BZZWW, Siemens Material Number 11416778). The recall is due to a defect where the scanner does not confirm the integrity of read barcode data using the check-digit when reading Code 39 barcodes.
The affected units were distributed only to foreign markets. All units of this specific model and material number are included in the recall. The source text does not specify the exact foreign countries or facilities where these scanners were distributed.
Consumers and facilities with these scanners should stop using them and contact Siemens Healthcare Diagnostics Inc. for instructions on how to proceed. The source text does not provide specific contact details or a return address, so users should refer to the official FDA recall notice or contact the manufacturer directly for further guidance.
The recalled product
- Product
- RP500e Handheld Barcode Scanner, Zebra Model: DS4308 - HC0062BZZWW, Siemens Material Number (SMN) 11416778
- Manufacturer
- Siemens Healthcare Diagnostics Inc
- Hazard
- Affected units
- 436
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All units
Distribution
Distribution scope not specified by the agency.
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