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.
Recall
- Recall Number
- Z-2060-2018
- Event Number
- 80067
- Firm
- Shimadzu Medical Systems
- FEI Number
- 1000125362
- Product Code
- IZI
- Status
- Terminated
- Root Cause
- Software design
- Initiated
- January 12, 2018
- Terminated
- February 24, 2022
- Address
- 20101 S Vermont Ave, Torrance, CA, 90502-1328
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.
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.
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.
US Nationwide in the states of IL, WA, MI, TX, AZ, CA, LA, FL, SC, and NJ.
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