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Shimadzu Medical Systems Recall: MODEL: X-RAY TV SYSSTEM SONIALVISION safire17

Shimadzu Medical Systems Recall: MODEL: X-RAY TV SYSSTEM SONIALVISION safire17 is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Shimadzu Medical Systems; Product: MODEL: X-RAY TV SYSSTEM SONIALVISION safire17; Reason for recall: It was found that the irradiated x-ray may exceed the xray

Recalling firmShimadzu Medical Systems
ProductMODEL: X-RAY TV SYSSTEM SONIALVISION safire17
Reason for recallIt 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.
ClassificationClass II (moderate — may cause temporary or reversible health consequences)
StatusOngoing
DistributionU.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
Recall initiated20220110
Recall numberZ-0869-2022
Categorydevice
StateCA
CountryUnited States

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