Shimadzu Medical Systems: Medical Device Recall in 2022 - (Recall #: Z-0869-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

MODEL: X-RAY TV SYSSTEM SONIALVISION safire17

Product Classification:

Class II

Date Initiated: January 10, 2022

Date Posted: April 13, 2022

Recall Number: Z-0869-2022

Event ID: 89596

Reason for Recall:

It was found that the irradiated x-ray may exceed the xray radiation dose rate specified in CFR 1020.32 in some specific case of fluoroscopic mode due to inadequate adjusting criteria in installation.

Status: Ongoing

Product Quantity: 12 systems

Code Information:

Model: SonialVision safire: Generator Number: D150-40 Serial Numbers: 3M5249D41006 3M5249D2A004 3M5249D34001 3M5249D37006 3M5249D32012 3M5249D35002 3M5249D1C013 3M5249D31009 3M5249D29002 3M5249D33003 3M5249D2C004 3M5249D22013

Distribution Pattern:

U.S.: AK, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OR, PA, RI, SC, SD, TN, TX, WA, and WV. O.U.S.: N/A

Voluntary or Mandated:

FDA Mandated