Recall Z-1292-2024— SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION

Name: FDA recall Z-1292-2024
Creator: U.S. Food and Drug Administration
Published: 2024-01-29

Class II · Ongoing

Class II FDA medical device recall by SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION, initiated 2024-01-29. It names one FDA 510(k) clearance: K123508. Product: 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..

Recalling firm: SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION
Classification: Class II
Status: Ongoing
Initiated: 2024-01-29
Firm location: Kyoto, N/A, Japan

510(k) clearances named in this recall

1 on FDA's record

K123508 — TRINIASShimadzu Corporation·cleared 2014-02-26

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.