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Shimadzu Medical Systems Recall 89253

Description: Digital Angiography System Bransist safire Generator Model D150GC-40

Shimadzu Medical Systems Recall 89253 Information

Mandated?FDA Mandated
Recall NumberZ-0654-2022
Event ID89253
Event DescriptionDigital Angiography System Bransist safire Generator Model D150GC-40
Product TypeDevices
DistributionU.S.: CA, FL, GA, IL, IN, KY, LA, MI, MS, OH, PA, SC, TN, TX and WA O.U.S.: Not provided.
Recall ReasonDue to the inadequate adjusting criteria in installation, the system generator on two Digital Angiography Systems, the irradiated x-ray may exceed the x-ray radiation dose rate in fluoroscopic mode.
Device Classification20220309
Device Code InfoGenerator Model: D150GC-40 Serial Number Range - 0161Q81103 to 3M99D3A55001 Specific Generator Serial Number/SMS ID: 3M99D3A24001/SMS20120038 3M99D3A4B001/SMS20140084 3M99D3A55001/SMS20150030 0161Q83701/SMS20080542 0161Q82204/SMS20080045 0161Q82302/SMS20080043 0161Q82304/SMS20080046 0261Q80901/SMS20100011 3M7A1600B001/SMS20080286 3M99D2622001/SMSMA110079 0161Q84501/SMS20090038 3M7A1600C001/SMS20200285 3M7A16A1A001/SMSMA110013 3M99D3A1C001/SMS20110202 0161Q84103/SMS20090099 0161Q83603/SMS20080505 0161Q83702/SMS20080580 0161Q83703/SMS20080581
Center Classification Date20220227
Recall Initiation Date20211216
Recalling FirmShimadzu Medical Systems
Initial Notification Letter
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