Digital Angiography System generator may exceed safe radiation dose rates
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.
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 is an FDA Class II recall for a medical device with risk of radiation dose rates exceeding safe limits. The hazard is potential rather than confirmed, fitting the rubric criterion for risk-of-harm products where injury has not been reported.
Plain-English summary
The FDA has recalled 28 Digital Angiography Systems manufactured by Shimadzu Medical Systems (Generator Model: D150GC-40) due to a defect in the installation adjustment process. When not properly adjusted during installation, the system generator may produce x-ray radiation dose rates that exceed safe fluoroscopic imaging limits, potentially exposing patients and staff to higher-than-intended radiation levels.
The recalled systems were distributed across the United States in California, Florida, Georgia, Illinois, Indiana, Kentucky, Louisiana, Michigan, Mississippi, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, and Washington. Specific affected systems are identified by serial numbers and SMS IDs provided by the manufacturer.
Healthcare facilities that have received any of the recalled systems should verify their system's serial number against the manufacturer's list. Facilities should contact Shimadzu Medical Systems to ensure proper installation adjustment and verification that radiation dose rates are within safe operating parameters.
The recalled product
- Product
- Digital Angiography System Shimadzu Trinias Generator Model: D150GC-40
- Manufacturer
- Shimadzu Medical Systems
- Category
- Medical Device — Imaging System
- Affected units
- 28
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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