Z-0869-2022 Class II Ongoing
FDA device recall Z-0869-2022 was initiated by Shimadzu Medical Systems on January 10, 2022 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 12 systems.
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