FDA-Device2018-09-26Class II
ddR Formula B X-ray System, Model ddR Formula B X-ray system used for imaging
Swissray Medical
Hazard
Potential for bucky (the part that holds the grid and is moveable to position the patient) moving unexpectedly.
Sold states
Worldwide Distribution: US (Nationwide) and to countries of: Austria, Dubai, China. Germany, Libya, Malaysia, Russia, and South Africa.
Affected count
27 devices in US
Manufactured in
Hohenrainstrasse 61, N/A, Hochdorf, N/A, Switzerland
Products
ddR Formula B X-ray System, Model ddR Formula B X-ray system used for imaging
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3191-2018Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief