Z-0983-2014 Class II Terminated

Recalled by Invivo Corporation — Orlando, FL

FDA device recall Z-0983-2014 was initiated by Invivo Corporation on December 4, 2013 and is designated Class II. 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. The recall status is terminated (terminated September 12, 2016). Affected quantity: 299.

Recall Details

Product Type
Devices
Report Date
February 26, 2014
Initiation Date
December 4, 2013
Termination Date
September 12, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
299

Product Description

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.

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.

Distribution Pattern

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

Code Information

Model 865471 Lot or serial Numbers: US23200154, US23200155, US23200156, US23200157, US23200158, US23200159, US23200160, US23200161, US23200162, US23200163, US23200164, US23200165, US23200166, US23200167, US23200168, US23200169, US23200170, US23200172, US23200173, US23200176, US23200177, US23200178, US23200179, US23200180, US23200181, US23200182, US23200183, US23200184, US23200185, US23200186, US23200187, US23200188, US23200189, US23200190, US23200191, US23200192, US23200193, US23200194, US23200195, US23200196, US23200197, US23200198, US23200199, US23200200, US23200201, US23200202, US23200203, US23200204, US23200205, US23200206, US23200207, US23200208, US23200209, US23200210, US23200211, US23200212, US23200213, US23200214, US23200215, US23200216, US23200217, US23200218, US23200219, US23200220, US23200221, US23200222, US23200223, US23200224, US23200225, US23200226, US23200227, US23200228, US23200229, US23200230, US23200231, US23200232, US23200233, US23200234, US23200235, US23200236, US23200237, US23200238, US23200239, US23200240, US23200241, US23200242, US23200243, US23200244, US23200245, US23200246, US23200247, US23200248, US23200249, US23200250, US23200251, US23200252, US23200253, US23200254, US23200255, US23200256, US23200258, US23200259, US23200260, US23200261, US23200262, US23200263, US23200264, US23200265, US23200266, US23200267, US23200268, US23200269, US23200270, US23200271, US23200272, US23200273, US23200274, US23200275, US23200276, US23200277, US23200278, US23200279, US23200280, US23200281, US23200282, US23200283, US23200284, US23200285, US23200286, US23200287, US23200288, US23200289, US23200290, US23200291, US23200292, US23200293, US23200294, US23200295, US23200296, US23200297, US23200298, US23200299, US23200300, US23200301, US23200302, US23200303, US23200304, US23200305, US23200306, US23200307, US23200308, US23200309, US23200310, US23200311, US23200312, US23200313, US23200314, US23200315, US23200316, US23200317, US23200318, US23200319, US23200320, US23200321, US23200322, US23200323, US23200324, US23200325, US23200326, US23200327, US23200328, US23200329, US23200330, US23200331, US23200332, US23200333, US23200334, US23200335, US23200336, US23200337, US23200338, US23200339, US23200340, US23200341, US23200342, US23200343, US23200344, US23200345, US23200346, US23200347, US23200349, US23200350, US23200351, US23200352, US23200353, US23200354, US23200355, US23200356, US23200357, US23200358, US23200359, US23200360, US23200361, US23200362, US23200363, US23200364, US23200365, US23200366, US23200367, US23200368, US23200369, US23200370, US23200371, US23200372, US23200373, US23200374, US23200375, US23200376, US23200377, US23200378, US23200379, US23200380, US23200381, US23200382, US23200383, US23200385, US23200386, US23200387, US23200388, US23200389, US23200390, US23200391, US23200393, US23200394, US23200395, US23200397, US23200398, US23200399, US23200400, US23200401, US23200402, US23200403, US23200405, US23200406, US23200407, US23200408, US23200410, US23200411, US23200413, US23200414, US23200415, US23200416, US23200417, US23200419, US23200421, US23200422, US23200423, US23200424, US23200425, US23200427, US23200428, US23200429, US23200431, US23200434