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Terminated

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 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.

FDA Recall Z-0983-2014 · Posted 2014-02-14

Recalling FirmInvivo Corporation
Recall StatusTerminated
Product CodeMWI
Date Initiated2013-12-04
Date Terminated2016-09-12
Product Quantity299

Reason for Recall

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.

Firm 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 Philips representative: 877-468-4861 option 1, then option 2. Philips apologizes for any inconveniences caused by this problem.

Root Cause

Component design/selection

Distribution Pattern

Worldwide Distribution - USA (nationwide) and the countries of Australia, Austria, Denmark, France, Germany, Netherlands, Poland, Singapore, Sweden, Switzerland and United Kingdom.

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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