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U.S. Department of Health and Human Services

Class 2 Device Recall Flex Cardio Patient Monitoring System

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  Class 2 Device Recall Flex Cardio Patient Monitoring System see related information
Date Initiated by Firm August 11, 2017
Create Date November 09, 2017
Recall Status1 Open3, Classified
Recall Number Z-0082-2018
Recall Event ID 78465
510(K)Number K101571  
Product Classification Monitor,physiological,patient(without arrhythmia detection or alarms) - Product Code MWI
Product Xper Flex Cardio PhysioMonitoring system
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. The Xper Flex Cardio physiomonitoring system may be used to display and analyze surface ECG (electrocardiogram), respiration, invasive pressure, Sp02 (Pulse Oximetry), End Tidal C02 (carbon dioxide) and non-invasive pressure waveforms; surface body temperature and thermal cardiac output curves. The system is capable of processing/analyzing information such as multi-channel ECG signals and displaying a graphical ST segment map. The Xper Flex Cardio physiomonitoring system makes measurements that assist physicians and other clinicians to evaluate a patient's overall cardiopulmonary performance, conductive system and general vascular status.
Code Information Model 453564621791 and 453564621801 - ALL Flex Cardio Devices, Revision C
Recalling Firm/
Manufacturer		 Invivo Corporation
12151 Research Pkwy Ste 200
Orlando FL 32826-3286
For Additional Information Contact Contact your Philip representative
407-275-3220
Manufacturer Reason
for Recall		 Intermittent communication between the host system and the Flex Cardio
FDA Determined
Cause 2		 Software Design Change
Action On August 2017 the firm sent letters to their consignees indicating the following: This document contains important information for the continued safe and proper use of your equipment Please review the following information with all members of your staff who need to be aware of the contents of this communication. It is important to understand the implications of this communication. Please retain a copy with the equipment Instruction for Use. ------------------------------------------- A problem has been detected in the Philips Xper Flex Cardio Patient Monitoring System (Flex Cardio) that, if it were to recur, could pose a risk for patients or users. This Field Safety Notice is intended to inform you 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 or users " the actions planned by Philips to correct the problem. Because of intermittent communication between the host system and the Flex Cardio, it is possible for any of the following conditions to occur: " Inability of the Flex Cardio to connect to the host system. " Boom Monitor (display) may not display all active waveform and/or vital sign data. " Delayed audible and visual alarms at the Flex Cardio and Boom Monitor respectively, due to a mismatch between the alarm limits on the host system and the Flex Cardio/Boom Monitor. " After patient admission and case initiation at the host system, the case may not be fully transmitted to the Flex Cardio. In this case, the Boom Monitor in the exam/procedure room will display vital sign data, but the Flex Cardio will not provide audible alarms. " After patient discharge and case termination at the host system, case termination may not be transmitted to the Flex Cardio. In this case, the Boom Monitor in the exam/procedure room will continue to display vital sign data, and the Flex Cardio will continue to provide audible alarms. Our re
Quantity in Commerce 529
Distribution Worldwide Distribution - US including AK, AL, AZ, CA, CO, DE, FL, GA, IA, ID, IL, KY, LA, MA, MI, MO, NC, NE, NM, NY, OH, OR, OK, PA, SD, TN, TX, VA, WA, WV and Internationally to Germany, Hungary, India, Netherlands, Russia, Saudi Arabia, South Africa and Tunisia.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = MWI and Original Applicant = WITT BIOMEDICAL CORP
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