Home / Recalls / Shimadzu Medical Systems / Z-0654-2022

Z-0654-2022 Class II Ongoing

Recalled by Shimadzu Medical Systems — Torrance, CA

Recall Details

Product Type
Devices
Report Date
March 9, 2022
Initiation Date
December 16, 2021
Termination Date
N/A
Voluntary/Mandated
FDA Mandated
Product Quantity
18

Product Description

Digital Angiography System Bransist safire Generator Model D150GC-40

Reason for Recall

Due 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.

Distribution Pattern

U.S.: CA, FL, GA, IL, IN, KY, LA, MI, MS, OH, PA, SC, TN, TX and WA O.U.S.: Not provided.

Code Information

Generator 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

Other recalls by Shimadzu Medical Systems

  • Z-0869-2022 Class II — MODEL: X-RAY TV SYSSTEM SONIALVISION safire17 (January 10, 2022)
  • Z-0868-2022 Class II — MODEL: X-RAY TV SYSTEM SONIALVISION G4 (January 10, 2022)
  • Z-0867-2022 Class II — MODEL: X-RAY R/F SYSTEM FLUOROspeed X1 (January 10, 2022)
  • Z-0655-2022 Class II — Digital Angiography System Shimadzu Trinias Generator Model: D150GC-40 (December 16, 2021)
  • Z-0556-2021 Class II — MH-200S, system with Ceiling Suspended C-arm Support - Product Usage: intended (November 18, 2020)
  • Z-0555-2021 Class II — Trinias, Digital Angiography System containing a MH-200, Ceiling Suspended C-arm (November 18, 2020)
  • Z-0554-2021 Class II — Bransist Safire, Digital Angiography System containing a MS-200 Ceiling Suspende (November 18, 2020)
  • Z-0534-2021 Class II — Shimadzu Mobile X-Ray System, MobileDaRt Evolution (MX8 Version), with adjustabl (November 9, 2020)
  • Z-2591-2020 Class II — Trinias DAP Meter, a component of the Digital Anglo System Trinias contained wit (November 4, 2019)
  • Z-2060-2018 Class II — Sonialvision Safire II, Model #: DAR-8000f Product Usage: This angiographic (January 12, 2018)