Z-1292-2024 Class II Ongoing
FDA device recall Z-1292-2024 was initiated by SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION on January 29, 2024 and is designated Class II. Reason for recall: Due to capacitor manufacturing issue, their is a potential that Flat Panel Device may have abnormal display or no function. The recall status is ongoing. Affected quantity: 1.
Recall Details
- Product Type
- Devices
- Report Date
- March 20, 2024
- Initiation Date
- January 29, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1
Product Description
Shimadzu, Trinias, Digital Angiography System
Reason for Recall
Due to capacitor manufacturing issue, their is a potential that Flat Panel Device may have abnormal display or no function.
Distribution Pattern
US Nationwide distribution in the states of OH.
Code Information
Serial Number: 41EFFF7D3001/UDI: (01)04540217058020