Company: Invivo Corporation
Date of Enforcement Report: 8/27/2014
Class lI:
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. Recall Number Z-2270-2014
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/MANUFACTURER
Invivo Corporation, Orlando, FL on 6/30/2014 Voluntary: Firm Initiated recall is ongoing
VOLUME OF PRODUCT IN COMMERCE
573 devices
DISTRIBUTION
Nationwide and Internationally
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