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.
FDA Recall Z-2867-2016 · Posted None
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Recalling FirmInvivo Corporation
Recall StatusTerminated
Product CodeMWI
Date Initiated2014-09-14
Date Terminated2016-12-14
Product Quantity639 units
Reason for Recall
Frozen Display Numerics and Disabled Menu Keys after extended run time. This customer notification was sent August 22, 2014.
Firm 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.
Root Cause
Software in the Use Environment
Distribution Pattern
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
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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