Digital angiography and radiography systems may remain energized when switched off
Digital angiography and radiography systems are being recalled because contactors in the high voltage generator may weld together, leaving the power supply energized when the system is off.
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: FDA Class II recall where a welded contactor can leave the system energized after it is switched off, a risk of harm with no injuries reported in the source.
Plain-English summary
Several imaging systems sharing the UD150G-40 / D150GC-40 high voltage generator are being recalled, including the Trinias, BRANSIST safire and BRANSIST alexa digital angiography systems and the RADspeed Pro digital radiography system. The action covers 3,487 units, identified by the system serial numbers in the recall notice.
The stated reason is that electromagnetic contactors within the high voltage generator may weld together, resulting in current being supplied to the power supply even if the power is off. The FDA classified the action as Class II.
Distribution was worldwide, including nationwide in the United States. The systems are installed in healthcare facilities rather than sold to consumers.
Facilities should identify affected systems using the model designations and serial numbers in the recall notice and follow the instructions issued by the manufacturer.
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…
- Manufacturer
- Shimadzu Medical Systems
- Affected units
- 3,487
Distribution
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