Home / Recalls / Shimadzu Medical Systems / Z-0655-2022

Z-0655-2022 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
28 systems

Product Description

Digital Angiography System Shimadzu Trinias 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 - 3M99D44446001to LM99D44B8001 Serial Number/SMS ID: 41E58C765001/SMS20160146 41EFCD78B001/SMS20190007 41EFD3B9A001/SMS20200009 41F005CB8001/SMS20210266 41E58C766001/SMS20160150 41B247746001/SMS20140089 41E58C757001/SMSHP150024 41E58C769001/SMS20160151 41E58C777001/SMS20170121 41EFCD77C001/SMS20180143 41F005B8C001/SMS20190052 41EFCD79A001/SMS20190366 41EFCD79C001/SMS20200285 41EFC73A5001/SMS20200263 41EFCD7A6001/SMS20200267 41EFC73A9001/SMS20200443 41E5E23AA001/SMS20200369 41E58C773001/SMSHP170001 41E58C977001/SMS20170424 41EFFF79A001/SMS20190376 41EFFF79C001/SMS20200031 41EFD3B9C001/SMS20200066 41E58C76B001/SMS20170288 41E58C775001/SMS20170134 41E58C776001/SMS20170135 41F005B91001/SMS20190019 41B24774C001/SMSMA140084 41EFCD7AC001/#N/A

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-0654-2022 Class II — Digital Angiography System Bransist safire 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)