Recall Z-2266-2015 ยท MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Philips Electronics North America Corporation
Invivo Expression MRI Patient Monitoring System.
| Date | Jul 27, 2015 (initiated Jun 17, 2015) |
| Status | Terminated |
| Reason | The device's labeling inaccurately indicates Endotracheal as a body temperature application site. The FlexTEMP reusable temperature sensor is not intended to be used for endotracheal placement. The application site should be listed as Esophageal. |
| Root cause | Labeling False and Misleading |
| Action | An URGENT Medical Device Correction was sent to all consignees by letter June 2015 regarding the Invivo Expression MRI Patient Monitoring System FlexTEMP Application Site explaining the reason for the affected labeling. |
| Quantity | 697 devices. |
| Distribution | Worldwide Distribution-US (nationwide) including the states of AL, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OR, OK, PA, SC, TN, TX, UT, VA, VT, WA, WI, WV, WY, and Alaska, Hawaii and the District of Columbia, and the countries of |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K124061 | MRI PATIENT MONITORING SYSTEM (MODEL 865214) Invivo Corporation, Feb 22, 2013 |