Recall Z-0983-2014 ยท MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Invivo Corporation
Invivo Corporation Expression Information Portal (Model IP5) is intended to be used as a secondary display control unit, where the device monitors the vital signs of a patient undergoing an MRI procedure from the MR control room, induction room, or recovery room and then outputs the measured patient data to a hospital information system (HIS). The Expression Information Portal (Model IP5), a disp
| Date | Feb 14, 2014 (initiated Dec 4, 2013) |
| Status | Terminated |
| Reason | Invivo Corporation located at 12151 Research Parkway, Orlando, FL 32826 is recalling the Expression Information Portal (Model IP5). Upon power up, the IP5 may fail to produce audio. |
| Root cause | Component design/selection |
| Action | Philips Healthcare sent an "URGENT - MEDICAL DEVICE RECALL" letter dated December 4, 2013, to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Customers were instructed to refer to the "Action to be Taken by Customer/User section on the attached pages. A Philips representative will contact the customer regarding their affected devices. All affected devices will have a firmware update installed to correct the problem free of charge. If you need any further information or support concerning this problem, please contact your local |
| Quantity | 299 |
| Distribution | Worldwide Distribution - USA (nationwide) and the countries of Australia, Austria, Denmark, France, Germany, Netherlands, Poland, Singapore, Sweden, Switzerland and United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K121424 | EXPRESSION INFORMATION PORTAL Invivo Corporation, Jun 13, 2012 |