Recall Z-0654-2022— Shimadzu Medical Systems

Name: FDA recall Z-0654-2022
Creator: U.S. Food and Drug Administration
Published: 2021-12-16

Class II · Ongoing

Class II FDA medical device recall by Shimadzu Medical Systems, initiated 2021-12-16. It names one FDA 510(k) clearance: K062360. Product: Digital Angiography System Bransist safire Generator Model D150GC-40. Reason: Due to the inadequate adjusting criteria in installation, the system generator on two Digital Angiography Systems, the irradiated x-ray may exceed the x-ray radiation dose rate in fluoroscopic mode..

Recalling firm: Shimadzu Medical Systems
Classification: Class II
Status: Ongoing
Initiated: 2021-12-16
Firm location: Torrance, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K062360 — BRANSIST SAFIREShimadzu Corp.·cleared 2006-10-05

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

Digital Angiography System Bransist safire Generator Model D150GC-40

Reason for recall

Due to the inadequate adjusting criteria in installation, the system generator on two Digital Angiography Systems, the irradiated x-ray may exceed the x-ray radiation dose rate in fluoroscopic mode.

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