FDA recall Z-3191-2018

Swissray Medical · Class II · device

Product

ddR Formula B X-ray System, Model ddR Formula B X-ray system used for imaging

Reason for recall

Potential for bucky (the part that holds the grid and is moveable to position the patient) moving unexpectedly.

Distribution

Worldwide Distribution: US (Nationwide) and to countries of: Austria, Dubai, China. Germany, Libya, Malaysia, Russia, and South Africa.

Key facts

Status
Ongoing
Initiation date
2016-11-18
Report date
2018-09-26
Voluntary/Mandated
Voluntary: Firm initiated
Location
Hochdorf, N/A, Switzerland

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3191-2018