Digital Angiography System Generators May Emit Excessive X-Ray Radiation
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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This FDA Class II recall involves a risk-of-harm medical device where radiation dose rates may exceed safe limits. No injuries or illnesses have been reported, placing it at the High severity level per the rubric criterion for risk-of-harm products without documented adverse events.
Plain-English summary
Shimadzu Medical Systems is recalling Digital Angiography System Bransist safire Generator Model D150GC-40 units due to a radiation dose safety hazard.
The affected systems may emit x-ray radiation exceeding the rated dose rate during fluoroscopic mode operation. This issue arises from inadequate adjusting criteria applied during system installation. Eighteen units with specific generator serial numbers have been identified as affected.
The systems are distributed across 15 U.S. states: California, Florida, Georgia, Illinois, Indiana, Kentucky, Louisiana, Michigan, Mississippi, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, and Washington.
Healthcare facilities using these systems should contact Shimadzu Medical Systems or the FDA for corrective measures. No patient injuries have been reported at this time.
The recalled product
- Product
- Digital Angiography System Bransist safire Generator Model D150GC-40
- Manufacturer
- Shimadzu Medical Systems
- Hazard
- Affected units
- 18
Distribution
Part of a larger recall action
This product is one of 2 recalled by Shimadzu Medical Systems under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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