FDAMay 1, 2018device

OmniDiagnost Classic X-ray system Angiographic and Diagnostic, Product Nos. 70859, 708023, 708024, 708025

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

The fixation of the upper and lower tilt actuator, of the Omnidiagnost system might break off and the table will start to rotate from 0 to + 90 /- 90 degree with high speed. This rotating movement can not be stopped by the user. This could potentially lead to the patient falling off the table. There is a risk of injury for the patient, user, or bystander.

What to do

FDA enforcement status: Terminated

Brands named

philips medical systems nederlandsphilipsphilips medical

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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