Shimadzu Trinias Digital Angiography System Recalled for Capacitor Defect
Shimadzu has recalled the Trinias Digital Angiography System due to a capacitor manufacturing issue that could cause abnormal display or system malfunction. No injuries have been reported.
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 a medical device recall where a manufacturing defect creates a risk of device malfunction during clinical use. FDA classified it as Class II. No illnesses or injuries have been reported, which prevents a higher severity rating, but the potential failure of a critical imaging device during procedure qualifies as a risk-of-harm product without reported injury.
Plain-English summary
Shimadzu Corporation is recalling the Trinias Digital Angiography System due to a capacitor manufacturing defect. Affected units, identified by serial number 41EFFF7D3001, may experience abnormal display output or complete loss of function.
The defect affects the flat panel display component of the system. If the capacitor fails, the display may function abnormally or cease to function entirely during clinical use.
The recall affects units distributed in the United States, specifically in Ohio. Healthcare facilities and operators of affected units should contact the manufacturer for guidance on inspection and replacement procedures. No patient injuries or illnesses have been reported to date.
The recalled product
- Product
- Shimadzu, Trinias, Digital Angiography System
- Manufacturer
- SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION
- Affected units
- 1
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Serial Number: 41EFFF7D3001/UDI: (01)04540217058020
Distribution
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