FDA Device recall Z-0614-2019
Xper Flex Cardio Physiomonitoring System, Software versions 1.5.16.0322 and 1.6.1.0390, Model Numbers 453564241901, 453564241911, 453564483…
- FDA Device
- Class II
- terminated
- Published 2018-12-26
On 2018-12-26 the FDA classified a Class II recall of Xper Flex Cardio Physiomonitoring System, Software versions 1.5.16.0322 and 1.6.1.0390, Model Numbers 453564241901, 453564241911, 453564483… by Philips Electronics North America, citing 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 dev….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0614-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-11-15 |
| Published | 2018-12-26 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Philips Electronics North America |
| Distribution | n/a |
Product
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
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.
Identifiers
| code_info | US1251000031 US1311000006 US1407000009 US1419000044 US1438000118 US1446000275 US1547001419 US1610001769 US16250…US1251000031 US1311000006 US1407000009 US1419000044 US1438000118 US1446000275 US1547001419 US1610001769 US1625002302 US1638002539 US1450000330 US1746001254 US1311000077 US1417000003 US1511000589 US1319000051 US1537001287 US1736000931 US1604001618 US1623002140 153 US1251000021 US1203010332 US1604001569 US1407000057 US1324000017 420 421 428 251 616 US1234000045 14 US1537001306 45 US1603001509 US1617002012 US1438000113 US1334000026 US1239000047 US1203010392 US1417000036 1213 US1319000082 US1608001676 US1611001852 US1324000025 US1731000712 US1609001745 US1334000028 US1248000022 US1638002517 US1638002591 US1644002662 US1644002668 US1644002682 US1546001353 US1203010414 US1424000022 US1523000858 US1547001364 US1547001374 US1547001394 US1547001395 US1610001753 US1626002429 US1201010146 US1202010179 US1244000031 US1244000058 US1505000520 US1534001212 US1738001102 US1203010380 US1644002701 US1505000552 US1523000883 US |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0614-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.