Recall Z-2432-2020 ยท CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Siemens Healthcare Diagnostics Inc
RP500e Handheld Barcode Scanner, Zebra Model: DS4308 - HC0062BZZWW, Siemens Material Number (SMN) 11416778
| Date | May 27, 2020 |
| Status | Terminated |
| 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 let |
| Quantity | 436 |
| Distribution | Foreign distribution only. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K192240 | RAPIDPoint 500e Blood Gas System Siemens Healthcare Diagnostics, Inc., Mar 27, 2020 |