Recall Z-0082-2018 · MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)

Invivo Corporation

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,

Date	Aug 11, 2017
Status	Terminated
Reason	Intermittent communication between the host system and the Flex Cardio
Root cause	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) t
Quantity	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.
FDA record	Open on fda.gov

510(k) clearances named in this recall

K101571

XPER INFORMATION MANAGEMENT AND FLEX CARDIO PHYSIOMONITORING SYSTEMS
Witt Biomedical Corp, Oct 26, 2010