FDA Device recall Z-0655-2022
Digital Angiography System Shimadzu Trinias Generator Model: D150GC-40
- FDA Device
- Class II
- ongoing
- Published 2022-03-09
On 2022-03-09 the FDA classified a Class II recall of Digital Angiography System Shimadzu Trinias Generator Model: D150GC-40 by Shimadzu Medical Systems, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0655-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-12-16 |
| Published | 2022-03-09 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Shimadzu Medical Systems |
| Distribution | CA, FL, GA, IL, IN, KY, LA, MI, MS, OH, PA, SC, TN, TX, WA |
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.
Identifiers
| code_info | Generator Model: D150GC-40 Serial Number Range - 3M99D44446001to LM99D44B8001 Serial Number/SMS ID: 41E58C765001/S…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0655-2022%22
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