Recall Z-0983-2014— Invivo Corporation

Name: FDA recall Z-0983-2014
Creator: U.S. Food and Drug Administration
Published: 2013-12-04

Class II · Terminated

Class II FDA medical device recall by Invivo Corporation, initiated 2013-12-04, terminated 2016-09-12. It names one FDA 510(k) clearance: K121424. Product: 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: 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..

Recalling firm: Invivo Corporation
Classification: Class II
Status: Terminated
Initiated: 2013-12-04
Terminated: 2016-09-12
Firm location: Orlando, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K121424 — EXPRESSION INFORMATION PORTALInvivo Corporation·cleared 2012-06-13

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.