Medical device recalls Moderate risk

Philips North America Llc recalls Philips DXR System, DuraDiagnost 4.1. Stationary X-Ray System.

Recall date
March 10, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1553-2025
FDA classification
Class II
Brand / firm
Philips North America Llc
Sold / distributed
Worldwide - US Nationwide distribution in the states of AK, FL, KS, MS, NH, NY, OR, PA, TX, WI and the countries of Argentina, Australia, Canada, Chile, China, Germany, Hungary, India, Indonesia, Italy, Kenya, Mexico, Netherlands, New Zealand, Oman, Pakistan, Peru, Poland, Romania, Russian Federati…

Why it was recalled

Potential for collimator to fall as a result of incorrect installation.

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 DXR System, DuraDiagnost 4.1. Stationary X-Ray System.

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