FDA recall Z-1292-2024

SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION · Class II · device

Product

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

US Nationwide distribution in the states of OH.

Key facts

Status
Ongoing
Initiation date
2024-01-29
Report date
2024-03-20
Voluntary/Mandated
Voluntary: Firm initiated
Location
Kyoto, N/A, Japan

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1292-2024