FDA Medical Device Recalls (openFDA)
Siemens Healthcare Diagnostics Inc: RP500e Handheld Barcode Scanner, Zebra Model: DS4308 - HC0062BZZWW, Siemens Material Number (SMN) 11416778
- Recall number
- Z-2432-2020
- Recalling firm
- Siemens Healthcare Diagnostics Inc
- Product
- RP500e Handheld Barcode Scanner, Zebra Model: DS4308 - HC0062BZZWW, Siemens Material Number (SMN) 11416778
- Status
- Terminated
- Initiated
- 2020-05-27
- Posted
- not on file
- Terminated
- 2021-01-12
- Reason
- The scanner is not confirming the integrity of read barcode data using the check-digit when reading Code 39 barcodes.
- 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
- 436
- Distribution
- Foreign distribution only.
- Lot, serial or model codes
- All units
- 510(k) numbers
- ["K192240"]
- PMA numbers
- not on file
- Product code
- CHL
- Firm FEI
- 3002637618
- Firm city
- Norwood
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28