Recall Z-2867-2016 ยท MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Invivo Corporation
Philips Expression Information Portal (IP5) Model 865471. The IP5 is intended to be used as a secondary display control unit for the Expression MRI Patient Monitoring System and the Expression MR200 MRI Patient Monitoring System.
| Date | Sep 14, 2014 |
| Status | Terminated |
| Reason | Frozen Display Numerics and Disabled Menu Keys after extended run time. This customer notification was sent August 22, 2014. |
| Root cause | Software in the Use Environment |
| Action | A recall notification letter was sent to hospitals who purchased the recalled product via UPS March 2014. The letter instructed users to power cycle the IP5 unit every day. This is done by pressing the power button on the side of the unit. Customers were instructed to communicate the recall to all those subject and to attach an addendum to the IP5 Instructions for Use. The firm advised customers to call their Philips representative, option 1, then option 2, if they had any questions or concerns. |
| Quantity | 639 units |
| Distribution | Worldwide distribution. US nationwide, Australia, Austria, Denmark, France, Germany, Iceland, Ireland, Italy, Netherlands, Norway, Poland, Saudi Arabia, Singapore, Slovenia, Spain, Sweden, Switzerland, United Arab Emirates, and England |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K121424 | EXPRESSION INFORMATION PORTAL Invivo Corporation, Jun 13, 2012 |