Shimadzu Medical Systems 2022-04-13 Health serious FDA
Health · FDA · Recall #FDA-Z-0869-2022
MODEL: X-RAY TV SYSSTEM SONIALVISION safire17 Recall
Issued April 13, 2022 · Shimadzu Medical Systems
In April 2022, Shimadzu Medical Systems recalled the MODEL: X-RAY TV SYSSTEM SONIALVISION safire17, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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.
What you should do
- 1 Stop using MODEL: X-RAY TV SYSSTEM SONIALVISION safire17 right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Shimadzu Medical Systems to arrange your fda mandated. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (FDA Mandated):
Recall details
- Brand
- Shimadzu Medical Systems
- Category
- Health
- Recall date
- April 13, 2022
- Units affected
- Not reported
- Sold at
- 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
- Recall number
- FDA-Z-0869-2022
- Made in
- United States
- Issuing agency
- FDA
In context
- Shimadzu Medical Systems has 1 recall in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 870th Health recall we've logged in 2022.