Recall Z-0614-2019 ยท DQK Computer, Diagnostic, Programmable
Philips Electronics North America Corporation
Xper Flex Cardio Physiomonitoring System, Software versions 1.5.16.0322 and 1.6.1.0390, Model Numbers 453564241901, 453564241911, 453564483321, 453564483331, 453564621791, 453564621801, 453564669081
| Date | Nov 15, 2018 |
| Status | Terminated |
| Reason | There are 3 issues: 1) Under certain conditions, real time waveforms may not be accurately plotted or displayed. 2) The oxygen saturation (SpO2) numeric value displayed on the device may freeze. 3) In auto cycle mode, if the NIBP communication is lost, the pump would not cycle and the non-invasive blood pressure (NIBP) numeric value displayed on the device would not update. |
| Root cause | Software Design Change |
| Action | The firm initiated the recall on X by letter. The letter explained the issues, potential risk, and provided workarounds for the consignee to use until the new software is ready for release. |
| Quantity | 651 units |
| Distribution | worldwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K101571 | XPER INFORMATION MANAGEMENT AND FLEX CARDIO PHYSIOMONITORING SYSTEMS Witt Biomedical Corp, Oct 26, 2010 |