Recall Z-0869-2022— Shimadzu Medical Systems

Name: FDA recall Z-0869-2022
Creator: U.S. Food and Drug Administration
Published: 2022-01-10

Class II · Ongoing

Class II FDA medical device recall by Shimadzu Medical Systems, initiated 2022-01-10. It names one FDA 510(k) clearance: K190373. Product: MODEL: X-RAY TV SYSSTEM SONIALVISION safire17. Reason: It was found that the irradiated x-ray may exceed the xray radiation dose rate specified in CFR 1020.32 in some specific case of fluoroscopic mode due to inadequate adjusting criteria in installation..

Recalling firm: Shimadzu Medical Systems
Classification: Class II
Status: Ongoing
Initiated: 2022-01-10
Firm location: Torrance, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K190373 — SonialVision G4Shimadzu Corporation·cleared 2019-03-15

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

MODEL: X-RAY TV SYSSTEM SONIALVISION safire17

Reason for recall

It was found that the irradiated x-ray may exceed the xray radiation dose rate specified in CFR 1020.32 in some specific case of fluoroscopic mode due to inadequate adjusting criteria in installation.

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