Medical device recalls Moderate risk

Philips Electronics North America Corporation recalls MultiDiagnost Eleva; x-ray system. Product Codes: 708032, 708036

Recall date
July 19, 2016
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2307-2016
FDA classification
Class II
Brand / firm
Philips Electronics North America Corporation
Sold / distributed
Worldwide distribution. US nationwide, Canada, Algeria, ARGENTINA, Australia, Austria, Belgium, China, Colombia, Czech Republic, Denmark, Egypt, Estonia, Faroe Islands, Finland, France, French Guiana, Germany, Greece, Hong Kong, Indonesia, Ireland, Israel, Italy, Jersey, Jordan, Republic of Korea,…

Why it was recalled

The two bolts that attach the clamping plate to the lateral shaft may break, which could cause the c-arm to move laterally forward, slide out of its bearings, and sag

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

What was recalled

MultiDiagnost Eleva; x-ray system. Product Codes: 708032, 708036

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