MODEL: X-RAY TV SYSSTEM SONIALVISION safire17
Reported: April 13, 2022 Initiated: January 10, 2022 #Z-0869-2022
Product Description
MODEL: X-RAY TV SYSSTEM SONIALVISION safire17
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.
Details
- Recalling Firm
- Shimadzu Medical Systems
- Units Affected
- 12 systems
- Distribution
- 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
- Location
- Torrance, CA
Frequently Asked Questions
What product was recalled? ▼
MODEL: X-RAY TV SYSSTEM SONIALVISION safire17. Recalled by Shimadzu Medical Systems. Units affected: 12 systems.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 13, 2022. Severity: Moderate. Recall number: Z-0869-2022.
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