FDAFDA · Food and drugs·Recall number Z-1292-2024
Shimadzu, Trinias, Digital Angiography System
Published March 20, 2024 · Recall initiated: January 29, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Due to capacitor manufacturing issue, their is a potential that Flat Panel Device may have abnormal display or no function.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION
- Distributor
- US Nationwide distribution in the states of OH.
- Lot
- Serial Number: 41EFFF7D3001/UDI: (01)04540217058020
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Japan
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