Digital Angiography System Shimadzu Trinias Generator Model: D150GC-40 — Class II medical device recall Z-0655-2022
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-0655-2022 |
|---|---|
| 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 | 28 systems |
| Serial numbers | 41B247746001/SMS20140089, 41B24774C001/SMSMA140084, 41E58C757001/SMSHP150024, 41E58C765001/SMS20160146, 41E58C766001/SMS20160150, 41E58C769001/SMS20160151, 41E58C76B001/SMS20170288, 41E58C773001/SMSHP170001, 41E58C775001/SMS20170134, 41E58C776001/SMS20170135, 41E58C777001/SMS20170121, 41E58C977001/SMS20170424, 41E5E23AA001/SMS20200369, 41EFC73A5001/SMS20200263, 41EFC73A9001/SMS20200443, 41EFCD77C001/SMS20180143, 41EFCD78B001/SMS20190007, 41EFCD79A001/SMS20190366, 41EFCD79C001/SMS20200285, 41EFCD7A6001/SMS20200267, 41EFD3B9A001/SMS20200009, 41EFD3B9C001/SMS20200066, 41EFFF79A001/SMS20190376, 41EFFF79C001/SMS20200031, 41F005B8C001/SMS20190052 and 2 more |
| Model numbers | D150GC-40 |
Product
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.
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-0655-2022. 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.