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U.S. Department of Health and Human Services

Class 2 Device Recall PHILIPS Xper Flex Cardio Physiomonitoring System

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  Class 2 Device Recall PHILIPS Xper Flex Cardio Physiomonitoring System see related information
Date Initiated by Firm March 14, 2018
Create Date May 14, 2018
Recall Status1 Terminated 3 on April 30, 2021
Recall Number Z-1867-2018
Recall Event ID 79611
Product Classification Monitor, physiological, patient (without arrhythmia detection or alarms) - Product Code MWI
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.
Code Information 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/ 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Recalling Firm/
Manufacturer		 Invivo Corporation
12151 Research Pkwy Ste 200
Orlando FL 32826-3286
For Additional Information Contact
407-275-3220
Manufacturer 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.
FDA Determined
Cause 2		 Software design
Action The firm initiated their recall by letter on March 14, 2018. The Field Safety Notice informed the consignee about: " what the problem is and under what circumstances it can occur " the actions that should be taken by the customer / user in order to prevent risks for patients " the actions planned by Philips to correct the problem. If further information or support concerning this problem is needed, the consignee was directed contact the local Philips representative: 800-669-1328 option 2, then option 3.
Quantity in Commerce 4375 units
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, Russian Fed, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Kingdom, Utd. Arab Emir, Uzbekistan and Vietnam.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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