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Recall Observatory FDA recall evidence

Device product

Shimadzu, Trinias, Digital Angiography System

Z-1292-2024

January 29, 2024

Class II

Product summary

Firm
SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION
Event
Event 93933
Status
Ongoing
Classification
Class II
Quantity
1
Official record key
device-enforcement:Z-1292-2024

Official wording

Reason: Due to capacitor manufacturing issue, their is a potential that Flat Panel Device may have abnormal display or no function.

Code information: Serial Number: 41EFFF7D3001/UDI: (01)04540217058020

Distribution pattern: US Nationwide distribution in the states of OH.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Due to capacitor manufacturing issue, their is a potential that Flat Panel Device may have abnormal display or no function.