Invivo Corporation recalls Philips Expression MR200 MRI Patient Monitoring System.

Recall date

October 22, 2014

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0958-2015

FDA classification

Class II

Brand / firm

Invivo Corporation

Sold / distributed

CA, FL, IN, KY, MN, NC, NJ, NY, OK, SD and TX Netherlands, Poland and United Kingdom.

Why it was recalled

The MR 200 devices failed the initial power up test due to capacitor short and hi-pot testing; possible loss of Patient Monitoring or User/Service Electrical Shock.

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 MR200 MRI Patient Monitoring System.