FDA (Devices) recall action 89253
The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.
Due to the inadequate adjusting criteria in installation, the system generator on two Digital Angiography Systems, the irradiated x-ray may exceed the x-ray radiation dose rate in fluoroscopic mode.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Shimadzu Medical Systems is recalling Digital Angiography System generators due to potential excessive x-ray radiation in fluoroscopic mode. Installation issues may cause radiation dose rates to exceed safe limits.
Shimadzu recalled 28 Digital Angiography Systems with Generator Model D150GC-40 due to inadequate installation adjustment criteria that may cause x-ray radiation dose rates to exceed safe fluoroscopic imaging limits.