FDA Device recall Z-1867-2018
PHILIPS Xper Flex Cardio Physiomonitoring System, Model Numbers: 453564241901, 453564483321, 453564621791, and 989803199561 (international…
- FDA Device
- Class II
- terminated
- Published 2018-05-23
On 2018-05-23 the FDA classified a Class II recall of PHILIPS Xper Flex Cardio Physiomonitoring System, Model Numbers: 453564241901, 453564483321, 453564621791, and 989803199561 (international… by Invivo, citing the real-time numeric value for ventricular end-diastolic pressure (EDP) displayed on the Live Display may be inaccurate. Because ventricular pressure monitoring is only performed….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1867-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-03-14 |
| Published | 2018-05-23 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Invivo |
| Distribution | US |
Product
PHILIPS Xper Flex Cardio Physiomonitoring System, Model Numbers: 453564241901, 453564483321, 453564621791, and 989803199561 (international only) The Xper Flex Cardio physiomonitoring system is used to facilitate invasive investigation of heart and vascular, disease when non-invasive indicators warrant such. Its users, responsible to interpret the data made available, will be professional health care providers, such as physicians, registered nurses, cardiovascular technicians, radiology technicians, and other clinical health care providers.
Reason
The real-time numeric value for ventricular end-diastolic pressure (EDP) displayed on the Live Display may be inaccurate. Because ventricular pressure monitoring is only performed in the cardiac catheterization procedure room using the FC2010 device, the FC2020 device, which is used in the Pre or Post-Op Holding Areas, is not impacted by this issue.
Identifiers
| code_info | Model Number: 453564241901 Serial Numbers/UDI (if available): US1203010330 US1203010371 US1203010373 US1203010382…Model Number: 453564241901 Serial Numbers/UDI (if available): US1203010330 US1203010371 US1203010373 US1203010382 US1203010400 US1203010413 US1203010421 US1311000007 US1311000009/ (01)00884838083523(21)US1239000009 US1311000017/ (01)00884838083523(21)US1331000034 US1239000009 US1331000034 US1231000061 US1108010053 US1202010217 US1234000060 US1337000038 US1337000040 US1337000043 US1343000024 US1334000021 US1234000066 US1202010242/ (01)00884838083523(21)US1202010242 US1244000002/ (01)00884838083523(21)US1244000002 US1251000087/ (01)00884838083523(21)US1251000087 US1202010168 US1203010284 US1244000061 US1251000005 US1203010302/ (01)00884838083523(21)US1203010302 US1244000016/ (01)00884838083523(21)US1203010340 US1231000038/ (01)00884838083523(21)US1231000038 US1234000024/ (01)00884838083523(21)US1234000024 US1244000016/ (01)00884838083523(21)US1244000016 US1244000040/ (01)00884838083523(21)US1244000040 US1244000066/ (01)00884838083523(21)US1244000066 |
|---|
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-1867-2018%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.