Medical device recalls Moderate risk

Swissray Medical recalls ddR Formula B X-ray System, ddR Formula B Product Usage: X-ray system used for imaging

Recall date
August 9, 2016
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-3248-2018
FDA classification
Class II
Brand / firm
Swissray Medical
Sold / distributed
US Nationwide

Why it was recalled

Possible injury due to movement of the arm, calibration loss and communication loss.

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

What was recalled

ddR Formula B X-ray System, ddR Formula B Product Usage: X-ray system used for imaging

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