Digital Angiography System Bransist safire Generator Model D150GC-40 — Class II medical device recall Z-0654-2022

Ongoing recall by Shimadzu Medical Systems, reported 2022-03-09, distributed in CA, FL, GA, IL, IN, KY, LA, MI…. Due to the inadequate adjusting criteria in installation, the system generator on two Digital Angiography Syst

Recall number	`Z-0654-2022`
Product type	Medical device
Classification	Class II
Status	Ongoing
Voluntary or mandated	FDA mandated
Recalling firm	Shimadzu Medical Systems, Torrance, CA, United States
Recall initiated	2021-12-16
Classified	2022-02-27
Reported by FDA	2022-03-09
Distributed	CA, FL, GA, IL, IN, KY, LA, MI, MS, OH, PA, SC, TN, TX, WA
Quantity	18
Serial numbers	`0161Q82204/SMS20080045`, `0161Q82302/SMS20080043`, `0161Q82304/SMS20080046`, `0161Q83603/SMS20080505`, `0161Q83701/SMS20080542`, `0161Q83702/SMS20080580`, `0161Q83703/SMS20080581`, `0161Q84103/SMS20090099`, `0161Q84501/SMS20090038`, `0261Q80901/SMS20100011`, `3M7A1600B001/SMS20080286`, `3M7A1600C001/SMS20200285`, `3M7A16A1A001/SMSMA110013`, `3M99D2622001/SMSMA110079`, `3M99D3A1C001/SMS20110202`, `3M99D3A24001/SMS20120038`, `3M99D3A4B001/SMS20140084`, `3M99D3A55001/SMS20150030`
Model numbers	`D150GC-40`

Product

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0654-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.