FDA Enforcement
Class II
Ongoing
Shimadzu, Trinias, Digital Angiography System
Recall: Z-1292-2024
·
Reported March 20, 2024
Enforcement
- Recall Number
- Z-1292-2024
- Event ID
- 93933
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- March 20, 2024
- Initiation Date
- January 29, 2024
- Classification Date
- March 14, 2024
- Address
- Nishinokyo Kuwabara -Cho, Nakagyo-Ku; 1, Kyoto, N/A, N/A, Japan
Description
Shimadzu, Trinias, Digital Angiography System
Reason
Due to capacitor manufacturing issue, their is a potential that Flat Panel Device may have abnormal display or no function.
Code Info
Serial Number: 41EFFF7D3001/UDI: (01)04540217058020
Distribution
US Nationwide distribution in the states of OH.
Quantity
1