Shimadzu Medical Systems: Medical Device Recall in 2018 - (Recall #: Z-2060-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: January 12, 2018

Date Posted: June 20, 2018

Recall Number: Z-2060-2018

Event ID: 80067

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.

Status: Terminated

Product Quantity: 17

Code Information:

Serial #: 0161G68101, 0261G65303, 0261G65702, 0261G68204, 3M72BFB21001, 3M72BFB2A001, 3M72BFC2A001, 3M72BFC2C001, 3M72BFB32001, 3M72BFB32006, 3M72BFB33003,3M72BFC33001, 3M72BFC34001, 3M72BFB35005, 3M72BFC37002, 3M72BFC42001, 3M72BFB46002

Distribution Pattern:

US Nationwide in the states of IL, WA, MI, TX, AZ, CA, LA, FL, SC, and NJ.

Voluntary or Mandated:

Voluntary: Firm initiated