Recall Z-2270-2014 ยท MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Invivo Corporation
Philips IP5 Information Portal The Expression Information Portal (Model IP5), a display and device controller for Philips MRI patient monitoring systems, is intended for use by trained health care professionals to remotely monitor the vital signs of patients undergoing MRI procedures.
| Date | Aug 19, 2014 (initiated Jun 30, 2014) |
| Status | Terminated |
| Reason | The wireless function of the IP5 radio could be interrupted causing loss of wireless communication between the IP5 and host monitoring system. |
| Root cause | Process design |
| Action | The firm, Philips Healthcare, sent an "URGENT - Field Safety Notice" dated June 30, 2014 to its customers. The notice describes the product, problem and actions to be taken. The notice also provides the customers with instructions for use while waiting for the update to the IP5. A Philips representative will contact you regarding your affected device. If you need any further information or support concerning this issue, please contact your local Philips representative: 877-468-4861 option 1, then option 2. |
| Quantity | 573 devices. |
| Distribution | Worldwide distribution: US (nationwide) including states of: AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NH, NJ, MN, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, Hawaii, Alaska, and District of Columbia; and countries of: Austral |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K121424 | EXPRESSION INFORMATION PORTAL Invivo Corporation, Jun 13, 2012 |