Medical device recalls Moderate risk

Philips Electronics North America Corporation recalls Philips Healthcare System X-ray Tomography Computed :

Recall date
March 15, 2016
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0376-2017
FDA classification
Class II
Brand / firm
Philips Electronics North America Corporation
Sold / distributed
USA(nationwide) Distribution to the states of : AZ, NY, GA, UT, TN, TX, AR, NV, Il, FL, MS, LA, MD, MO, MA, OK, KY, WY, SC, ND, NE, DE, MI, WA, CT, RI, KS, OR, IN, PA, CA, NJ, NC, MN, AL and IA.

Why it was recalled

It was discovered the patient support tabletop may fail to move in the horizontal direction when it is commanded to do so during CT scans due to a potential mechanical linkage failure.

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 Healthcare System X-ray Tomography Computed :

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