Recall Z-2760-2016 ยท MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Invivo Corporation
The system provides the ability to transmit patient data files for storage, viewing and analysis at distributed locations via the intranet or Internet, or may function as a stand-alone device.
| Date | Oct 19, 2015 |
| Status | Terminated |
| Reason | Display of SpO2 and Non-Invasive Blood Pressure (NIBP) Measurements May Freeze |
| Root cause | Unknown/Undetermined by firm |
| Action | Phillips Medical Systems sent out a letter to their customers, dated October 19, 2015. The letter notified customers and distributors of the voluntary recall of the Xper Flex Cardio Patient Monitoring System, and identified the product issue as "Display o fSpO2 and NIBP measurements may freeze". Phillips assured customers that the recalled device can be used if each monitored patient is closely observed and not left unattended. These directions are directed within the instructions of the manual for regular use. Continued use is advised until Phillips contacts the individual customer to corre |
| Quantity | 2,929 |
| Distribution | Nationwide Distribution to the states of :AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TX, TN, UT, VA, WA, WI, WV, Alaska, Hawaii, & Washington, DC. Worldwide Distribution to the countrie |
| 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 |