FDA-Device2018-10-03Class II

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

Swissray Medical
Hazard

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

Sold states
US Nationwide
Affected count
26 units
Manufactured in
Hohenrainstrasse 61, Hochdorf, Switzerland
Products
ddR Formula B X-ray System, ddR Formula B Product Usage: X-ray system used for imaging

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3248-2018

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