MODEL: X-RAY TV SYSTEM SONIALVISION G4
Reported: April 13, 2022 Initiated: January 10, 2022 #Z-0868-2022
Product Description
MODEL: X-RAY TV SYSTEM SONIALVISION G4
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
- 176 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 SYSTEM SONIALVISION G4. Recalled by Shimadzu Medical Systems. Units affected: 176 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-0868-2022.
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