Medical device recalls Moderate risk

Philips Electronics North America Corporation recalls Philips DuraDiagnost X-ray systems: DuraDiagnost (R1.0, Product Number 712210) DuraDiagnost (R2.0, Product Number 71221…

Recall date
May 31, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2322-2017
FDA classification
Class II
Brand / firm
Philips Electronics North America Corporation
Sold / distributed
Worldwide Distribution - US Distribution to the states of : Ca and Oh., and to the countries of: Australia, Libya, China, Mayotte, Mexico, France, United Kingdom, Germany, Ecuador, Australia, Spain, Switzerland, Macedonia, Uzbekistan, Kuwait, Malaysia, Netherlands, Argentina, Chile, Colombia, Egypt…

Why it was recalled

Tube arm assembly could fall down due to cracked welding joints

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 DuraDiagnost X-ray systems: DuraDiagnost (R1.0, Product Number 712210) DuraDiagnost (R2.0, Product Number 712211) DuraDiagnost (R3.0, Product Number 712211)

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