Philips Healthcare Informatics, Inc. recalls IntelliSpace PACS 4.4, Product number 837507 - Product Usage: intended to be used by trained professionals, including b…

Recall date

April 19, 2019

Source

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

Recall number

Z-2338-2020

FDA classification

Class II

Brand / firm

Philips Healthcare Informatics, Inc.

Sold / distributed

Worldwide distribution - US Nationwide distribution including in the states of AZ, CA, FL, LA, MA, MI, MO, NC, NH, NY, OR, and TX. There was government distribution but no military distribution. The countries of Canada, Brazil, Ireland, New Zealand, United Arab Emirates, and the United Kingdom.

Why it was recalled

Images may potentially become corrupt while using the system.

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

What was recalled

IntelliSpace PACS 4.4, Product number 837507 - Product Usage: intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians.