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.
FDA Recall Z-2060-2018 · Posted None
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Recalling FirmShimadzu Medical Systems
Recall StatusTerminated
Product CodeIZI
Date Initiated2018-01-12
Date Terminated2022-02-24
Product Quantity17
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.
Firm Action
Shimadf0u sent an Urgent Voluntary Medical Device Recall Notice letter dated January 2018. The letter identified the affected product, problem and actions to be taken. For questions contact Shimadzu representative or contact Shimadzu National Technical Support at 800-228-1429.
Root Cause
Software design
Distribution Pattern
US Nationwide in the states of IL, WA, MI, TX, AZ, CA, LA, FL, SC, and NJ.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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