[pending] Digital Angiography System Trinias:UD150G-40 / D150GC-40; Digital Angiography System BRANSIST safire
Pending LLM rewrite. Source: FDA_DEVICE Z-2294-2026.
What this means for you
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: Pending LLM scoring against the rubric.
Plain-English summary
Electromagnetic contactors within high voltage generator may weld together, resulting in current being supplied to power supply even if power is off.
The recalled product
- Product
- Digital Angiography System Trinias:UD150G-40 / D150GC-40; Digital Angiography System BRANSIST safire:UD150G-40 / D150GC-40; Digital Angiography System BRANSIST alexa:UD150G-40 / D150GC-40; Digital Radiography System RADspeed Pro: UD150B-40 / UD150V-40 / UD150L-40 / UD150L-40E/D15
- Manufacturer
- Shimadzu Medical Systems
- Category
- Medical Device — Devices
Distribution
Distributed nationwide across the United States.
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