Philips Electronics North America Corporation recalls MultiDiagnost Eleva with Flat Detector; x-ray system. Product Codes: 708034, 708037, 708038.

Recall date

July 19, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2305-2016

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 with Flat Detector; x-ray system. Product Codes: 708034, 708037, 708038.