Terminated

Xper Flex Cardio Physiomonitoring system. Used to facilitate invasive investigations of heart and vascular disease when non-invasive indicators warrant such.

FDA Recall Z-0263-2018 · Posted None

Recalling FirmInvivo Corporation

Recall StatusTerminated

Product CodeMWI

Date Initiated2017-08-18

Date Terminated2024-09-20

Product Quantity4,535

Reason for Recall

Intermittent communication between the host system and the FlexCardio

Firm Action

On August 24, 2017 Philips send the following communications to distributors and clients. Dear Distributor, Philips is initiating an action related to the Xper Flex Cardio Patient Monitoring System. The attached Field Safety Notice is intended to inform customers 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, users or servicers " the actions planned by Philips to correct the problem. It is imperative that all affected end users of the Xper Flex Cardio receive the attached Field Safety Notice. Because Philips sells these products through distributors, including your organization, we may not have the information necessary to contact all end users. Therefore, please send the attached Field Safety Notice to each customer to whom you have distributed one of the affected devices. A description of the affected device can be found in the Field Safety Notice attached. -- Dear Customer, 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, which could result in delays in diagnosis or treatment: " 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 ca

Root Cause

Software Design Change

Distribution Pattern

AK, AL, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KY, KS, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV and Puerto Rico Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Bulgaria, Cambodia, Canada, Cayman Island, Chile, China, Colombia, Congo, Cote D'Ivoire, Cuba, Cyprus, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, Georgia, Germany, Greece, Honduras, Hungary, Iceland, India, Indonesia, Iran, Ireland, Israel, Italy, Jordan, Kazakhstan, Kenya, Korea, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Maldives, Mauritius, Mexico, Morocco, Myanmar, Nepal, Netherlands, New Caledonia, New Zealand, Norway, Oman, Pakistan, Palestine, Panama, Papua, Paraguay, Philippines, Poland, Qatar, Reunion, Romania, Russian Federation, Saudi Arabia, Singapore, South Africa, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Vietnam, and Yemen

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K101571XPER INFORMATION MANAGEMENT AND FLEX CARDIO PHYSIOMONITORING SYSTEMSWitt Biomedical Corp · 2010-10-26

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.