Recall Z-0263-2018 ยท MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Invivo Corporation
Xper Flex Cardio Physiomonitoring system. Used to facilitate invasive investigations of heart and vascular disease when non-invasive indicators warrant such.
| Date | Aug 18, 2017 |
| Status | Terminated |
| Reason | Intermittent communication between the host system and the FlexCardio |
| Root cause | Software Design Change |
| 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 attach |
| Quantity | 4,535 |
| Distribution | 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, Ca |
| 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 |