FDANovember 9, 2020device
Shimadzu Mobile X-Ray System, MobileDaRt Evolution (MX8 Version), with adjustable handle option, Made in Japan - Product Usage: The device is intended to be used to take a film, CR or general radiography of patients in the hospital who cannot move and/or of outpatients in emergency.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
There is a potential that the adjustable handle option on the X-Ray system may have been installed with improper bolts. This could result in improper driving operation which could lead to harm of individuals around the device.
What to do
FDA enforcement status: Ongoing
Brands named
shimadzu medical systemsshimadzushimadzu medical
Recall history
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