Medical device recalls Moderate risk

Philips Healthcare Inc. recalls Mobile Diagnostic X-Ray System with Digital Panel

Recall date
November 28, 2012
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1706-2017
FDA classification
Class II
Brand / firm
Philips Healthcare Inc.
Sold / distributed
Nationwide (AR, AZ, CA, DE, FL, GA, IA, IL, IN, KS, MD, MI, MN, NC, NM, NY, OH, OR, PA, SC, TX, VT, WI)

Why it was recalled

When the operator moves an image to another view then the electronic marker might be placed at the wrong anatomical position in the resulting image.

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

What was recalled

Mobile Diagnostic X-Ray System with Digital Panel

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