Recall Z-2060-2018— Shimadzu Medical Systems

Name: FDA recall Z-2060-2018
Creator: U.S. Food and Drug Administration
Published: 2018-01-12

Class II · Terminated

Class II FDA medical device recall by Shimadzu Medical Systems, initiated 2018-01-12, terminated 2022-02-24. It names one FDA 510(k) clearance: K052500. Product: Sonialvision Safire II, Model #: DAR-8000f Product Usage: This angiographic x-ray system device intended to be used for the radiography in the hospital with X-ray devices. This device is operated and used by the physicians and X-ray technologist. The object of this device is total patient population.. Reason: When selecting serial radiography with a pulse rate of 7.5fps (including selecting a preset or changing the pulse rate using a temporary edit function) it was observed the indicated "irradiation time" on the X-ray Generator Console, as well as the "integral dose" on the external console of fluoroscopy, were reset to 0. There has been one report of this event..

Recalling firm: Shimadzu Medical Systems
Classification: Class II
Status: Terminated
Initiated: 2018-01-12
Terminated: 2022-02-24
Firm location: Torrance, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K052500 — DAR-8000FShimadzu Medical Systems·cleared 2005-10-17

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

Sonialvision Safire II, Model #: DAR-8000f Product Usage: This angiographic x-ray system device intended to be used for the radiography in the hospital with X-ray devices. This device is operated and used by the physicians and X-ray technologist. The object of this device is total patient population.

Reason for recall

When selecting serial radiography with a pulse rate of 7.5fps (including selecting a preset or changing the pulse rate using a temporary edit function) it was observed the indicated "irradiation time" on the X-ray Generator Console, as well as the "integral dose" on the external console of fluoroscopy, were reset to 0. There has been one report of this event.

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