Z-0869-2022 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- April 13, 2022
- Initiation Date
- January 10, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- FDA Mandated
- Product Quantity
- 12 systems
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.
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
Code Information
Model: SonialVision safire: Generator Number: D150-40 Serial Numbers: 3M5249D41006 3M5249D2A004 3M5249D34001 3M5249D37006 3M5249D32012 3M5249D35002 3M5249D1C013 3M5249D31009 3M5249D29002 3M5249D33003 3M5249D2C004 3M5249D22013