Recall archive / FDA device enforcement
Digital Angiography System Shimadzu Trinias Generator Model: D150GC-40 — FDA record Z-0655-2022
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Dec 16, 2021. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Digital Angiography System Shimadzu Trinias Generator Model: D150GC-40
- Reason
- 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.
- Classification
- Class II
- Recalling firm
- Shimadzu Medical Systems
- Quantity
- 28 systems
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0655-2022
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
U.S.: CA, FL, GA, IL, IN, KY, LA, MI, MS, OH, PA, SC, TN, TX and WA O.U.S.: Not provided.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Mar 9, 2022
- Recall initiation date
- Dec 16, 2021
- Center classification date
- Feb 27, 2022
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.