Recall Z-2270-2014— Invivo Corporation

Name: FDA recall Z-2270-2014
Creator: U.S. Food and Drug Administration
Published: 2014-06-30

Class II · Terminated

Class II FDA medical device recall by Invivo Corporation, initiated 2014-06-30, terminated 2016-12-14. It names one FDA 510(k) clearance: K121424. Product: Philips IP5 Information Portal 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: The wireless function of the IP5 radio could be interrupted causing loss of wireless communication between the IP5 and host monitoring system..

Recalling firm: Invivo Corporation
Classification: Class II
Status: Terminated
Initiated: 2014-06-30
Terminated: 2016-12-14
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

Philips IP5 Information Portal 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

The wireless function of the IP5 radio could be interrupted causing loss of wireless communication between the IP5 and host monitoring system.

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