Medical device recalls Moderate risk

Invivo Corporation recalls Philips Expression Information Portal (IP5) Model 865471. The IP5 is intended to be used as a secondary display control…

Recall date
September 14, 2014
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2867-2016
FDA classification
Class II
Brand / firm
Invivo Corporation
Sold / distributed
Worldwide distribution. US nationwide, Australia, Austria, Denmark, France, Germany, Iceland, Ireland, Italy, Netherlands, Norway, Poland, Saudi Arabia, Singapore, Slovenia, Spain, Sweden, Switzerland, United Arab Emirates, and England

Why it was recalled

Frozen Display Numerics and Disabled Menu Keys after extended run time. This customer notification was sent August 22, 2014.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Philips Expression Information Portal (IP5) Model 865471. The IP5 is intended to be used as a secondary display control unit for the Expression MRI Patient Monitoring System and the Expression MR200 MRI Patient Monitoring System.

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