Recall Z-2060-2018 ยท IZI System, X-Ray, Angiographic
Shimadzu Medical Systems
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.
| Date | Jan 12, 2018 |
| Status | Terminated |
| 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. |
| Root cause | Software design |
| 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. |
| Quantity | 17 |
| Distribution | US Nationwide in the states of IL, WA, MI, TX, AZ, CA, LA, FL, SC, and NJ. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K052500 | DAR-8000F Shimadzu Medical Systems, Oct 17, 2005 |