Z-1292-2024 Class II Ongoing
FDA device recall Z-1292-2024 was initiated by SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION on Jan 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
- Mar 20, 2024
- Initiation Date
- Jan 29, 2024
- 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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1292-2024
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026