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 warra
Check against the official notice below — it lists the full affected range.
Invivo Corporation is recalling the Philips Xper Flex Cardio Physiomonitoring System (Model Numbers 453564241901, 453564483321, 453564621791, and 989803199561 for international use) because the real-time numeric value for ventricular end-diastolic pressure (EDP) displayed on the Live Display may be inaccurate. The FC2010 device used in cardiac catheterization procedure rooms is affected by this issue, while the FC2020 device used in Pre or Post-Op Holding Areas is not impacted. A total of 4,375 units have been distributed worldwide, including throughout the United States and Puerto Rico, as well as to numerous countries across South America, Europe, Asia, Africa, and Oceania.
The recall source does not specify a remedy or corrective action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
Reason for recall: 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. Distribution: Worldwide Distribution - USA (nationwide) Distribution including Puerto Rico., and to the countries of : Argentina, Australia, Austria, Bangladesh, Belgium, Bulgaria, Canada, Chile, China, Cyprus, Egypt, Finland, France, Germany, Greece, Hungary, India, Indonesia, Iran, Ireland, Italy, Kazakhstan, Kenya, Malaysia, Mexico, Mauritius, Netherlands, New Zealand, Pakistan, Philippines, Poland, Romania, Quantity: 4375 units Lot/code info: 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 US1251000013/ (01)00884838083523(21)US1251000013 US1311000025/ (01)00884838083523(21)US1311000025 US1319000059/ (01)00884838083523(21)US1319000059 US1337000032/ (01)00884838083523(21)US1337000032 US1231000048/ (01)00884838084926(21)US1231000048 US1251000031/ (01)00884838084926(21)US1251000031 US1304000040/ (01)00884838084926(21)US1304000040 US1334000041/ (01)00884838084926(21)US1334000041 US1107010016 US1107010019 US1107010022 US1107010036 US1108010062 US1109010104 US1202010153 US1202010173 US1202010233 US1203010261 US1203010295 US1
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.