Medical device recalls Moderate risk

Philips North America, LLC recalls Philips TraumaDiagnost- a Stationary X-Ray System (Bucky System) Model: 720013 - Product Usage: general radiography.

Recall date
April 7, 2020
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1806-2020
FDA classification
Class II
Brand / firm
Philips North America, LLC
Sold / distributed
Worldwide distribution - US Nationwide distribution including the states of CA, ME, RI, TX, WI and the countries of Canada, Australia, Austria, France, Germany, Greece, Hungary, Ireland, Netherlands, Portugal, Slovenia, United Kingdom.

Why it was recalled

If the shaft breaks due to material fatigue, the trauma arm can fall down and may result in injury.

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 TraumaDiagnost- a Stationary X-Ray System (Bucky System) Model: 720013 - Product Usage: general radiography.

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